Director Of Regulatory Affairs Jobs in New Jersey

Job Title: Director Regulatory Affairs Company: Merck-Legacy Schering Plough Location: Roseland, NJ Description: Employer Information About Merck-Legacy Schering Plough Merck-Legacy Schering Plough View all our jobs

Job Title: Regulatory Affairs Manager - PHARMA ONLY Company: Alternative Resources Company Location: Piscataway, NJ Description: Role Title: Regulatory Affairs Manager Department/Group: Regulatory Career Level: Supervisor: Sr. Director – Regulatory Date: January, 2010 Position Overview n Responsible for the preparation and submission of IND/CTA and maintenance, in compliance to regulations, for the assigned project(s) n Responsible for all day-to-day regulatory submissions to FDA for the assigned project(s) n Responsible for providing strategic regulatory support to the assigned project(s) n Responsible for overseeing the Regulatory CRO(s) for ex-US regulatory submissions of the assigned project(s) n Responsible as Regulatory lead in the preparation of NDA n Responsible for post-approval maintenance of NDA Essential Job Responsibilities/Primary Activities Prepare and ensure quality day-to-day submissions to FDA within timeline (IND Amendments, Safety Reports, etc.) Draft the cover letters of FDA correspondence, meeting request, meeting briefing package, etc.; ensure proper review, finalization and timely submission of the documents Prepare and submit IND/CTA; ensure maintenance of IND, in compliance to regulations, for the assigned project(s) Orchestrate the preparation, review, and timely submission of IND annual reports Oversee the Regulatory Specialist and Administrative Assistant helping in the preparation of all types of regulatory submissions and maintenance of tracking of the submissions Work with the regional team for the planning of regulatory submissions including defining timeline Interact with the global team to collect the document components required for regulatory submissions Provide clarification or guidance to the team on the strategic regulatory issues; provide interpretation of the regulations to support/enhance team’s understanding on the regulatory requirements Keep the team(s) updated on the recent FDA initiatives and evolving therapeutic area-specific regulatory requirements Represent the RA functional area in the NDA preparation team and accomplish the assigned regulatory tasks including drafting of submission components such as labeling Interact/manage internal resource or external vendors preparing the eCTD IND or NDA Maintain the approved NDA in compliance with the regulations Assist in the preparation and conduct of meetings with the FDA Contribute to the review of internal SOPs and policies Performs other departmental duties as assigned Qualifications n Degree Required: Bachelors  Preferred: B.S (life science); Regulatory Affairs Certification (RAC) 5+ years of drug regulatory experience; in-depth knowledge of US regulations; prior experience in IND submission of new chemical entity (NCE), hands-on experience in preparation of different types of regulatory submissions, eCTD NDA submission experience is a plus; advanced MS Office skills (Word, Excel, Powerpoint); Proficiency with Adobe Acrobat to create and collate documents; excellent verbal and written communication skills Additional Information n Ability to think strategically and develop regulatory strategy for product development programs n Ability to interact with external consultants in strategy development sessions n Ability to work cohesively with a cross-cultural global development team n Ability to handle multiple priorities and mange time-line in a fast-pace environment Debra Pohl President, Pharmaceutical Recruitment Alternative Resources Company Register to View

Job Title: Regulatory Submission Manager - Regulatory Affairs Company: Eisai Inc. Location: Woodcliff Lake, NJ Description: Incumbent will be responsible for serving as the submission manager for regulatory submissions, serving the Regulatory Submission team leader, and communicating with IPT Project Mgmt function, Regulatory eDocumentation, RA Mgmt, and external business partners with respect to submission status, organizing and facilitating meetings. The Regulatory Submissions Manager develops the submission timeline with the submission team leader and the eDocumentation representative, maintains the submission timelines, collects status updates from the ePublishing and IPT subteam members, and updates the Project Management and RA Management regarding submission status and activities. The Regulatory Project Manager also has responsibilities for maintaining the regulatory affairs department submission calendar, and reporting on key projects to RA Mgmt as requested. In addition, the RA Project Manager is responsible for conducting training on the submission process for new teams, and new team members. Primary Responsibilities % of Time1. The Regulatory Submission Manager (RSM) for regulatory submissions arranges the submission team meetings, develops the agenda with the RA team leader, focuses the meetings on agenda items and dossier deliverables, and keeping the submission team meeting minutes. The RSMs role is to support and facilitate the Regulatory Submission team meetings, thereby enabling the Submission team leader to focus on technical content issues while the RSM manages the business functions 50%2. The Regulatory Submission Manager develops the submission timeline with the submission team leader and the eDocumentation representative, maintains the submission timelines, collects status updates from the Publishing Manager and IPT subteam members, and reports submission status and activities to Project Management and RA Management. 30%3. The Regulatory Project Manager maintains the regulatory affairs submission calendar, and reports on key submission milestones to Project Mgmt and RA Mgmt as requested. 10%4. The Regulatory Project Manager conducts submission process training for new teams and new team members. 10% 100%Qualifications and Expertise• Regulatory professional that understands regulatory submission/ePublishing requirements for filing original applications, complex supplements/variations and line extensions, as well as routine submissions.• Excellent communication skills required to interact effectively with IPT members and regulatory colleagues in gathering the necessary information required for submissions, and to proactively address sensitive issues with diplomacy and tact.• Applies good judgment and demonstrates initiative to resolve issues.• Expert understanding of Project Management tools and techniques.• Receives guidance from multiple sources by proactively seeking input to support task execution• Ensures submissions are processed in accordance with established SOPs.• Manages multiple resources within and across groups to meet project deliverables with regard to regulatory requirements• Understands the strengths and weaknesses of the team and plans to get the highest and best use of team members• Leads problem solving: facilitating team(s) to identify issues and propose solutions with respect to regulatory issues• Assists in resource allocation as needed

Job Title: Associate Director Director - Regulatory Affairs Company: Eisai Location: Woodcliff Lake, NJ Description: The incumbent will be responsible for developing and guiding the global regulatory strategy for assigned products, and serve as the core global regulatory representative on International Project Teams for assigned products and provide regulatory leadership.Other responsibilities include (burt are not limited to):Supervising the preparation of global regulatory submissions, and serving as the primary contact person with FDA for assigned products.Monitoring programs (development projects and approved products) so they comply with the required Health Authority Regulations and Laws.Reviewing and approving protocols, reports, and documents used in regulatory submissions.Overseeing overall regulatory labeling function for assigned marketed products.Providing regulatory input into US strategic marketing initiatives and ESI policies regarding advertising and promotional activities.Reviewing and approving all advertising and promotional materials for assigned products to insure that they comply with FDA regulations, as well as serving as primary contact person for DDMAC.Developing, implementing and maintaining regulatory procedures regarding review of advertising and promotional materials for US marketed productsKeeping abreast of all pertinent laws, regulations and guidances as they pertain to regulatory strategies and submissions. REQUIREMENTS - QUALIFICATIONS: Associate Director Director - Regulatory Affairs BS degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology, Pharmacology, Pharmacy or Nursing). PhD, PharmD, or comparable degree in the life sciences highly desired.Minimum 10-12 years of regulatory experience, with a track record of completed filings of IND's and NDA's to health authorities.Must have experience in interacting with the appropriate regulatory bodies (US and if possible EU and other countries).Must possess in-depth knowledge of appropriate Code of Federal Regulations, Regulatory Guidance Documents (US and EU) and ICH Regulations.Experience with regulatory reviews of promotional material and interaction with DDMAC.History of working in complex team environments with numerous/diverse stakeholders.Eisai

Job Title: DIRECTOR REGULATORY AFFAIRS Company: Career Developers Location: Nutley, NJ Description: DIRECTOR REGULATORY AFFAIRS Employment agency specializing in Information Technology, Life Sciences and Finance recruiting, permanent and consulting services.

Job Title: Regulatory Affairs Manager - Medical Devices Company: MRINetwork Location: Paterson, NJ Description: Regulatory Affairs ManagerMedical Devices  A medical device manufacturing company located in the northeastern US has an urgent need for a Regulatory Affairs professional with experience in 510k preparation and submissions, complaint handling, labeling, adverse event reports, and general regulatory affairs issues in the medical device industry. This is a strong and growing company with excellent promotability and benefits. This position carries the responsibility for the regulatory functions at the corporate level.  Additionally, you will have the opportunity to be a part of the product development team working with engineering and quality professionals to insure products in the pipeline are in compliance with applicable regulatory requirements.  Experience with European (EU) and Canadian submissions is a big plus. Prior history of successful submittals and 510k preparations is also a big plus. QUALIFICATIONS5+ years experience in Regulatory Affairs of medical devices  BS/BA minimum. Advanced degrees are a plusBroad knowledge of regulatory regulations and standards There is a relocation package available for the right candidate.  Please respond to this advertisement by attaching your resume in MS Word format to an email addressed to Register to View and John Boynton at MRI Atlanta Peachtree North will give you a call if you meet the requirements.  Please send a link if you are interested in joining my network of 8000+ industry executives on LinkedIn.

Job Title: Director Regulatory Affairs - Global RA - Regulatory Strategist Company: unknkown Location: Somerville, NJ Description: Director Regulatory Affairs - Global RA - Regulatory Strategist Director Regulatory Affairs - Global RA - Regulatory Strategist - Regulatory Affairs Leader - - Skills Required - Global RA, Regulatory Strategist, Director Regulatory Affairs, Associate Director, Oncology , Global, International, Submission, PhD, PharmD Director Regulatory Affairs - Global RA - Regulatory Strategist - Regulatory Affairs Leader -If you are a Director or Associate Director of Regulatory Affairs with International experience, and preferably a Phd/PharmD degree, please read on!An exciting opportunity to work for a brand name, top pharmaceutical company providing regulatory strategy and oversight into foreign markets. What you need for this position:-Experience as a Global Regulatory Strategist for the Pharmaceutical industry is required.-Phd or PharmD is a huge plus-at least 5 years working for a pharma/biotech in regulatory affairs-8 years total industry experience-Multiple therapeutic area expertise-Experience leading a team and leading projects-Working knowledge of regulations for drug development and registration activities-Ability to multi task and communicate effectivelyWhat you'll be doing:-Develop regulatory strategy for assigned products in foreign markets-Manage follow up after regulatory submission, manages response by regulatory authorities-Provides strategic and operational direction for therapeutic area group and appropriate organization-Mentor and manage junior level staffWhat's in it for you:-Excellent compensation package, including stock options, long term incentives and bonus structure-Excellent working environment-Very low (10%) travel-Highly visible position within an internationally respected organizationSo, If you are a Director or Associate Director of Regulatory Affairs with International experience, and preferably a Phd/PharmD degree, please apply today! - EB-DirectorRegAffairs - , , , , , CyberCoders CyberScientific

Job Title: Associate Director, Regulatory Affairs Operations: Stable and Growing Pharmaceutical Leader, NJ Company: Cornerstone Search Group, LLC Location: North Caldwell, NJ Description: Associate Director, Regulatory Affairs Operations:Stable and Growing Pharmaceutical Leader, NJ                                                          Summary: We are working closely with a Global Pharmaceutical Leader on a key search within their Regulatory Affairs group.  They are currently looking for an established regulatory affairs professional to lead the Regulatory Affairs function across life cycle management teams.  This position requires a high level of Regulatory Affairs strategy, business acumen, and leadership.  You will enjoy a very competitive compensation plan, as well as exceptional benefits.   Note: All inquiries and submissions are held in strict confidence (see our privacy policy below).   Location: North Caldwell, New Jersey area Compensation: Base compensation will be competitive based on your level of experience and will also include a double digit bonus and top-tier benefits. Attractive features about this position and company: In this role you will be responsible for a wide-ranging level of Regulatory Affairs responsibilities.  You will have the ability to be visible and growth potential is very real.Great location for those not only in NJ (North/East/West/Central), but also from NYC, Southern CT, or NY counties north of NYC.  Easily accessible from Route 80, 46, 287, and 3 as well as the NJ Turnpike and Garden State Parkway.This Company is annually rated as one of the most respected companies in the pharmaceutical industry. Responsibilities: Contribute to the Regulatory Affairs leadership function across life cycle management teams.Lead teams in developing strategy for products.Lead project management components to commercialize products.Implement strategic plans in coordinating and managing regulatory submissions.Maintain and establish working relationships with business teams. Ensure cross-functional perspectives/expertise is incorporated into regulatory plans.Manage decision-making and conflict resolution surrounding key regulatory issues.Collaborate with the finance team and functional management to ensure regulatory team has appropriate budget and resources to meet objectives. Requirements:Masters degree is greatly preferred.5+ years of relevant experience in regulatory affairs.Expertise in managing cross-functional regulatory affairs teams.Basic working knowledge of core industry processes: discovery, development, manufacturing, and marketing. Cornerstone’s Privacy PolicyCornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information.  Any information provided/shared with us will not to be shared with any parties outside of Cornerstone Search Group without your prior permission. Contact:Thomas FasciaSr. Manager, Specialized Pharmaceutical Practice Feel free to either send me or my research team an email with your confidential resume. Thomas Fascia: Register to View Research Team: Register to View  Cornerstone Search Group, LLC6 Campus DrParsippany, NJ 07054P Register to View x717F Register to View Web/URL: www.cornerstonesg.com   About Cornerstone Search Group, LLCCornerstone Search Group is a specialized Pharmaceutical | Biotechnology Executive Search & Recruitment firm located in heart of New Jersey's Pharmaceutical corridor. Cornerstone Search Group helps its Pharmaceutical | Biotechnology clients identify, attract and hire accomplished professionals from the experienced Staff Levels through the Senior Leadership ranks who are involved with the discovery, development and commercialization of drugs/therapeutic treatments for the US and international markets. Cornerstone Search Group's team of highly experienced Pharmaceutical | Biotechnology Specialty Consultants/Recruiters are adept at using their industry knowledge and contacts to generate desired results for their clients and candidates. Building better companies.  Building better careers.® Other OpportunitiesCornerstone Search Group is currently working on Executive Search & Recruitment assignments in several of the following business areas: Discovery, Clinical Research & Development, Medical Affairs and  Commercial/Marketing, and in several of the following functional areas: Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Data Management, Health Economics & Outcomes Research, Market Research, Medical Affairs, Medical Directors, Clinical Scientists, Medical/Drug Information, Medical/Scientific Communications, Medical Writing, Pricing & Reimbursement, Product/Brand Management, QA/QC, Pharmacovigilance & Drug Safety, Regulatory Affairs, Scientists, Sourcing and Pathologist.  Please visit our company’s web site for a comprehensive listing of available positions/opportunities at www.cornerstonesg.com.

Job Title: Senior Manager, Regulatory Affairs: Top Ranked Pharmaceutical Leader, NJ Company: Cornerstone Search Group, LLC Location: Montclair, NJ Description: Senior Manager, Regulatory Affairs:Top Ranked Pharmaceutical Leader, NJ  Summary: Our client is a stable and growing larger Pharmaceutical Company. They have one of the top two pipelines in the industry and are always ranked as a top company to work for.  They are currently in search for a seasoned regulatory affairs professional to run multiple RA projects across multiple therapeutic areas.  You will enjoy a very competitive compensation plan, as well as exceptional benefits.   Note: All inquiries and submissions are held in strict confidence (see our privacy policy below).   Location: Montclair, New Jersey area Compensation: Base compensation can range from $100k-$140k based on your level of experience and will also include a double digit bonus and top-tier benefits such as 100% tuition reimbursement, a generous 401(k) plan, and exceptional on-site facilities/perks including Child Care, On-site Gym, etc. Attractive features about this position and company: This Company is continuing to grow an already robust Regulatory Affairs department with multiple leading products as well as a stout pipeline.Opportunity.  You will serve as the “quarterback” who will be the crucial team member in regards to managing multiple projects. Growth.  There is a clear growth path within the company and we have seen many people advance their career from within.Great location for those not only in NJ (North/East/West/Central), but also from NYC, Southern CT, or NY counties north of NYC.  Easily accessible from Route 80, 46, 287, and 3 as well as the NJ Turnpike and Garden State Parkway.Firm has a strong reputation for taking care of its people.  They are annually ranked as a top employer to work for (Fortune, NJ Biz, and Science) and are also ranked by Mothers Magazine as a leading employer for working mothers.Responsibilities: In a nutshell, you will be responsible for managing multiple projects ranging in responsibility across the regulatory affairs department.Serve as the primary company spokes-person to Regulatory authorities.Develop regulatory strategies.Prepare regulatory submissions.Demonstrate leadership on the team and within the function to accomplish objectives.Coordinate activities personnel to ensure that tasks are completed within defined due dates and meet regulatory and departmental guidelines.Provide strategic advice to the company for the development of regulatory strategies and issue resolutionLiaise with FDA and other regulatory agencies for assigned development projectsManage all regulatory activities for development projects, including representation on the project development teamsSupervise regulatory document assembly, review and submission to regulatory agencies, while ensuring that the compilation and transmittal of regulatory submissions are completed within defined time schedules and meet established standardsParticipate and represent Regulatory in meetings and interacting with members of all development project teams to convey regulatory requirements and develop a strategy to meet divisional goalsCommunicate regulatory issues to functional areas and transmit regulatory concerns from functional areas to Regulatory Affairs senior management Requirements:Bachelors Degree, but an advanced degree (MS, PharmD, etc) is preferred.3-7 years of relevant experience in regulatory affairs.Basic working knowledge of core industry processes: discovery, development, manufacturing, and marketing.Demonstrated leadership skills.Communication and organizational skills.Excellent team and interpersonal skills. Commitment to performance measures of time, costs and quality. Cornerstone’s Privacy PolicyCornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information.  Any information provided/shared with us will not to be shared with any parties outside of Cornerstone Search Group without your prior permission. Contact:Thomas FasciaSr. Manager, Specialized Pharmaceutical Practice Feel free to either send me or my research team an email with your confidential resume. Thomas Fascia: Register to View Research Team: Register to View  Cornerstone Search Group, LLC6 Campus DrParsippany, NJ 07054P Register to View x717F Register to View Web/URL: www.cornerstonesg.com  About Cornerstone Search Group, LLCCornerstone Search Group is a specialized Pharmaceutical | Biotechnology Executive Search & Recruitment firm located in heart of New Jersey's Pharmaceutical corridor. Cornerstone Search Group helps its Pharmaceutical | Biotechnology clients identify, attract and hire accomplished professionals from the experienced Staff Levels through the Senior Leadership ranks who are involved with the discovery, development and commercialization of drugs/therapeutic treatments for the US and international markets. Cornerstone Search Group's team of highly experienced Pharmaceutical | Biotechnology Specialty Consultants/Recruiters are adept at using their industry knowledge and contacts to generate desired results for their clients and candidates. Building better companies.  Building better careers.® Other OpportunitiesCornerstone Search Group is currently working on Executive Search & Recruitment assignments in several of the following business areas: Discovery, Clinical Research & Development, Medical Affairs and  Commercial/Marketing, and in several of the following functional areas: Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Data Management, Health Economics & Outcomes Research, Market Research, Medical Affairs, Medical Directors, Clinical Scientists, Medical/Drug Information, Medical/Scientific Communications, Medical Writing, Pricing & Reimbursement, Product/Brand Management, QA/QC, Pharmacovigilance & Drug Safety, Regulatory Affairs, Scientists, Sourcing and Pathologist.  Please visit our company’s web site for a comprehensive listing of available positions/opportunities at www.cornerstonesg.com.

Job Title: Senior Program Manager of Regulatory Affairs Company: Kforce Clinical Research Staffing Location: Nutley, NJ Description: .mainbody .RightColumn .LeftColumn a .jlocation .jdetail .jtitle .jdescription .jFontstyle14 .jFontstats .jFontstyle13 .jFontstyle16 .jFontstyle17 .position .jFontstats Status: Full-Time, Employee Level: 2-5 Years Experience Job Location: Nutley, NJ Job Ref Code: OTNRC971214 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . About Kforce Clinical Research . . . . . . . . . . . . . Kforce Clinical Research offers more than 20 years of experience with a strong commitment to providing exceptional service by building great teams dedicated to operational excellence. Kforces long-term client relationships open the door to rewarding opportunities, giving candidates access to the worlds top biopharmaceutical companies. In addition to providing exciting opportunities, our Firm takes the time to get to know each candidates career aspirations, enabling Kforce to be their career advocate. Our clinical research specialty areas include: monitoring/site management, study management, regulatory affairs, drug safety, data management, data entry, clinical programming, biostatistics and quality assurance. Backed by approximately 1,900 staffing specialists, Kforce is committed to "Great People = Great Results" for our valued clients and candidates. Our Firm operates with 62 offices in 41 markets in North America and two in the Philippines. Kforce is an EEO/AA Employer . POSITION Senior Program Manager of Regulatory Affairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Job Description: At Kforce Clinical Research, we don't just offer jobs. We offer a rewarding career experience, complete with professional development opportunities and a great benefits package! We are intelligent business partners to some of the world's most valued pharmaceutical companies and have evolved to create models of operational excellence that incorporate Lean and Six Sigma philosophies. Using these tools, Kforce is able to better plan and anticipate work loads and thus minimize the peaks of work that can swamp you. This allows you to stay just as dedicated and still strike a balance between work and home. Currently, one of our top clients is in search of an exceptional Senior Program Manager of Regulatory Affairs in Nutley, NJ. Specific Accountabilities: Provide U.S. regulatory strategic direction as the U.S. regulatory lead of global teams and U.S. product teams for projects of moderate complexity and/or discrete components (line extensions and new indications) of larger projects of moderate complexityServe as the principal interface with primary reviewers from health authorities (FDA, etc.)Develop regulatory strategies, provide direction on health authority interactions, prepare regulatory submissions and demonstrates leadership on the team and within the function to accomplish business objectivesCoordinate activities of small groups of local personnel to ensure that tasks are completed within defined due dates and meet regulatory and departmental guidelinesManage special regulatory projects of moderate complexity, as assigned by othersDue to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. Requirements Include: 3-5 years of relevant experience in drug development including relevant experience in regulatory affairsBachelor's DegreeBasic working knowledge of core processes: discovery, development, manufacturing and marketingDemonstrated leadership skillsCommunication and organizational skillsExcellent team and interpersonal skillsCommitment to performance measures of time, costs, and qualityKforce Clinical Research has been serving the pharmaceutical industry since 1988. We are truly a career destination and the employer of choice for skilled, dedicated professionals like you. At Kforce, one of our core principles is: Great People = Great Results! This means that we will work to find you the right career match through exceptional customer service, a disciplined process, and personal respect. If you are qualified and interested in the excellent career opportunities we have for you, apply today!Apply for this job Great People = Great Results