Director Of Regulatory Affairs Jobs in New York

Job Title: Sr Mgr Regulatory Affairs Company: Siemens Healthcare Diagnostics Location: Tarrytown, NY Description: Company: Siemens Healthcare Diagnostics Inc.Division: SMSD - IVD OPSLocation: NY - TarrytownReq ID: 87153Position Title: Sr Mgr Regulatory AffairsExperience Level: Senior LevelEducation Required: Bachelors Degree or equivalent experienceTravel Required: YesCompany Description:Siemens Healthcare Diagnostics Inc. offers a broad portfolio of performance-driven diagnostic solutions that provide more effective and efficient ways to anticipate, diagnose, monitor and treat disease. Our products and services offer the right balance of science, technology and practicality across the healthcare continuum to provide medical professionals with the vital information they need to deliver better, more personalized healthcare to patients around the globe. Visit us at www.siemens.com/diagnostics .Siemens is an Equal Opportunity Employer encouraging diversity in the workplace.Job Description:This position will manage the priorities, regulatory projects, regulatory personnel, and other associated activities for the international regulatory group located at the Tarrytown site. This position will be responsible for preparing or providing country specific documentation to facilitate the registration of product in the international marketplace and will act as a liaison between the countries and the business. This position will also provide support for domestic submissions, provide support for team functions or projects, or other business priorities as needed..Additional Information:Travel Percentage: 10%

Job Title: Director, Regulatory Affairs Company: Regeneron Location: Tarrytown, NY Description: Regeneron is a biopharmaceutical Company that discovers, develops, and commercializes therapeutic medicines for the treatment of serious medical conditions. Regeneron currently markets ARCALYST (rilonacept) Injection for subcutaneous use for the treatment of a rare, inherited, inflammatory condition. The company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases and inflammatory diseases, and has preclinical programs in other diseases and disorders.With a strong research base and product focus, Regeneron is able to understand thoroughly the biology of specific disease states, discover potential therapeutic candidates and evaluate product candidates in clinical trials. Regeneron has developed several proprietary platform technologies, which it has incorporated into a comprehensive system that allows it to accelerate the discovery and design of fully human antibodies and move these candidates rapidly into clinical development.Position Summary:The Director, Regulatory Affairs is responsible for integrating and applying knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's preclinical and clinical drug development programs, policies, and procedures, to ensure the rapid and successful development and registration of Regeneron products while maintaining compliance with all regulatory requirements and commitments..Essential Duties and Responsibilities include, but are not limited to the following:*Leads multidisciplinary teams on the content, format, style and architecture of marketing applications (BLAs and MAAs) and the strategies for gaining regulatory approval. Writes and/or reviews eCTD sections and evaluates relative to stratgegy and for conformance with the regulatory requirements.*Contributes to multidisciplinary teams on the regulatory strategy for drug development including CMC, preclinical, and clinical requirements at different stages of development. Familiar with US and EU guidances/guidelines applicable to same.*Contributes to multidisciplinary teams on the regulatory requirements for publically shown materials, including prmotional materials.*Leads multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application, Clinical Trials Application (CTA) and the IMPD.*Liaison with competent regulatory authorities on routine matters and serve as the Regeneron lead for regulatory meetings with Agencies.*Supervises the preparation of IND (or CTA) amendments, annual reports and other routine regulatory submissions. Writes and/or reviews more strategic regulatory submissions such as briefing packages for FDA meetings or EU scientific advice proecdures.*Reviews critical analyses of data (clinical, preclinical and manufacturing) and independently develops interpretations and conclusions. Performs meaningful reviews of clinical/preclinical/manufacturing protocols and studies reports.*Manages the performance and development of staff. Leads training on applicable requirements for scientific staff as required. REQUIREMENTS - QUALIFICATIONS: Director, Regulatory Affairs Requirements:*A MD or PhD in Life Science or a related field and a minimum of 10 plus years in biotechnology/pharmaceutical industry of which a minimum of 5 years was in regulatory affairs.*Prior experience with biotechnology products a plus.*Works independently with all levels of mgmt internally and externally under the minimal supervision of the department head.*Team leadership experience, participates in hiring, termination, performance review and disciplinary processes.*Previous regulatory leadership experience with a global Phase 2/3 development program, including familiarity with CHMP processes/procedures. Direct experience with analgesic drug development highly desirable.*Expert knowledge of 21 CFR Parts 50, 54, 56, 58, 210, 211, 312, 314, 600, 601, and stays current on newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs.*Excellent communications, management and advanced negotiation are a must.We offer an extremely competitive compensation and benefits package including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.EOE/M/F/D/VReneneron

Job Title: Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDA Company: CyberCoders Location: New York, NY Description: Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDA .body .body h4 .body .section tr.oddRow a, a:link, a:visited Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDA near New York City, NY This job is open as of 2/26/2010. Apply Now! Not a fit for this job? Search other Associate Director Regulatory Affairs jobs! Are you an employer? Visit us for more info! Email this job to a friend - $1000 Location New York City, NY; Chicago, IL Salary $130,000 - $175,000 Education PhD Category Strategy - Planning Experience Required At least 2 Years Short Description Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDA Required Skills Regulatory, Manager RA, Associate Director Drug Regulatory Affairs, Pharmaceutical, Clinical, IND/NDA, Regulatory Strategy, biotech, global, life cycle teams Recruiter Erin Beagle Date Updated 2/26/2010 Skills Required Regulatory, Manager RA, Associate Director Drug Regulatory Affairs, Pharmaceutical, Clinical, IND/NDA, Regulatory Strategy, biotech, global, life cycle teams Job Description Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDAIf you are an Associate Director Regulatory Affairs, Manager of Regulatory Affairs, or Sr Manager of Regulatory, with a regulatory strategy background, a PhD or PharmD and IND/NDA experience, please read on!A top, multi-national pharmaceutical company based in Northern New Jersey, is looking for an Associate Director of Drug Regulatory Affairs/ Regulatory Strategist to join their team! If you aren't local to the NYC/North Jersey Metropolitan area, but posses the requisite experience, my client will provide a comprehensive relocation package to get you there!What you need for this position:-An Advanced degree - PhD or PharmD, is strongly preferred!-At least 5+ years of experience developing regulatory strategies in the pharma industry-IND/NDA writing/filing experience-A background in Clinical development is a plus!- Focus in Clinical Regulatory Strategy - not CMCWhat you'll be doing:-Developing regulatory strategy for a global pharmaceutical company-Working hand in hand with the Director of Global Drug REgulatory affairs and with Global drug life cycle teams-Managing and developing strategy for global submissions-Lead a team of regulatory professionals through implementation of your strategies and the submission process, as well as IND/NDAWhat's in it for you:-Extremely competitive salary and bonus structure-Opportunity to work in a global organization making a direct and immediate impact on the regulatory affairs groupSo, if you are you are an Associate Director Regulatory Affairs, Manager of Regulatory Affairs, or Sr Manager of Regulatory, with a regulatory strategy background, a PhD or PharmD and and IND/NDA experience, please apply today!Must be authorized to work in the United States on a full-time basis for any employer. Are you a fit for this position? Please Click Here to Apply! (your information will be kept strictly confidential!) Not a fit for this position? Click Here to Search Other CyberCoders Jobs! Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, or you may also: Email your resume in Word to: Register to View **Please do NOT change the email subject line in any way. You must keep the JobID: CC HotJobAp : EB-NJRegAD -- in the email subject line for your application to be considered.*** Erin Beagle - Executive Recruiter - CyberCoders Other Jobs

Job Title: Associate Director Regulatory Affairs - Regulatory - Manager RA Company: CyberCoders Location: New York City, NY Description: Associate Director Regulatory Affairs - Regulatory - Manager RA - Regulatory Strategy - IND/NDAIf you are an Associate Director Regulatory Affairs, Manager of Regulatory Affairs, or Sr Manager of Regulatory, with a regulatory strategy background, a PhD or PharmD and IND/NDA experience, please read on!A top, multi-national pharmaceutical company based in Northern New Jersey, is looking for an Associate Director of Drug Regulatory Affairs/ Regulatory Strategist to join their team! If you aren't local to the NYC/North Jersey Metropolitan area, but posses the requisite experience, my client will provide a comprehensive relocation package to get you there!What you need for this position:-An Advanced degree - PhD or PharmD, is strongly preferred!-At least 5+ years of experience developing regulatory strategies in the pharma industry-IND/NDA writing/filing experience-A background in Clinical development is a plus!- Focus in Clinical Regulatory Strategy - not CMCWhat you'll be doing:-Developing regulatory strategy for a global pharmaceutical company-Working hand in hand with the Director of Global Drug REgulatory affairs and with Global drug life cycle teams-Managing and developing strategy for global submissions-Lead a team of regulatory professionals through implementation of your strategies and the submission process, as well as IND/NDAWhat's in it for you:-Extremely competitive salary and bonus structure-Opportunity to work in a global organization making a direct and immediate impact on the regulatory affairs groupSo, if you are you are an Associate Director Regulatory Affairs, Manager of Regulatory Affairs, or Sr Manager of Regulatory, with a regulatory strategy background, a PhD or PharmD and and IND/NDA experience, please apply today!Must be authorized to work in the United States on a full-time basis for any employer.

Job Title: Manager, Regulatory Affairs & Government Relations Company: Just Energy Corp. Location: Albany, NY Description: Employer:                   Just EnergyJob Title:                    Manager, Regulatory Affairs & Government RelationsDepartment:               Regulatory AffairsReports To:                Executive VP, Regulatory and Legal AffairsOrganization:             Vicinity of Albany, New York Business Profile: Just Energy is one of North America’s leading electricity and natural gas retailers with offices in the U.S. and Canada.  Through its affiliates under its parent, Just Energy Income Fund, a publicly traded Income Trust (TSX:JE.UN), Just Energy provides over 1.6 million residential, small to mid-sized commercial and small industrial customers with the peace of mind that comes from knowing that they are protected from energy price volatility.  In addition, through its subsidiary National Home Services, Just Energy sells and rents high efficiency and tankless water heaters, and through its subsidiary Terra Grain Fuels, produces and sells wheat-based ethanol.  Just Energy is poised to become an industry leader in providing environmentally responsible energy supply solutions to consumers across North America. Just Energy continues to focus on growth, professional development and fostering an entrepreneurial spirit that has made the company what it is today.  We are looking for individuals interested in joining a fast-paced, dynamic, and growing company that is also a leader in the North American retail energy market.  We offer competitive compensation with incentive bonuses, group benefits, a dynamic working environment and opportunity for growth that is unparalleled. General Summary:This position will have responsibility for implementation and ongoing administration of regulatory oversight in certain regional markets, regulatory compliance and day-to-day support to the business units in the conduct of their sales of long term natural gas and electricity contracts and home services.Key Accountabilities:Managing and monitoring regulatory activities and proceedings/applications with local regulatory bodies and local/Federal government.Establishing and maintaining effective relationships with government, regulators, utilities and market participants and advocacy role with same.Advising business units on compliance with regulations and requirements for the marketing and sale of energy, and transactional and operational rules and related developments.Participation in external energy policy and technical committees and industry forums, and advocate for the interests of the business.Participation in internal development of regulatory strategies and policies which align/support business strategies.Communication and interaction with internal business units with regards to regulatory activities and developments. Qualifications:University Degree5-10 years experience in wholesale and retail enery markets in similar roleExcellent written and verbal communication skillsOrganization and analytical skillsNegotiation skillsThe ability to manage a diverse workload and tight timeframesAbility to work effectively with little supervisionExperience in specific U.S. jurisdictions – North East and/or Mid Western StatesTravel is required in this role Application Process: If you are interested in an opportunity with Just Energy, we hope to hear from you soon.  Note that additional details about the company can be found at the following websites: www.justenergy.com and www.je-un.ca Please send resume via email to Register to View and enusre you place the name of the position in the subject of the email.

Job Title: Sr Mgr Regulatory Affairs Company: Siemens Corporation Location: Tarrytown, NY Description: This position will manage the priorities, regulatory projects, regulatory personnel, and other associated activities for the international regulatory group located at the Tarrytown site. This position will be responsible for preparing or providing country specific documentation to facilitate the registration of product in the international marketplace and will act as a liaison between the countries and the business. This position will also provide support for domestic submissions, provide support for team functions or projects, or other business priorities as needed.

Job Title: Director, Regulatory Affairs (CMC) Company: Regeneron Pharmaceuticals, Inc. Location: Tarrytown, NY Description: Regeneron Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. With a strong research base and product focus, Regeneron is able to understand thoroughly the biology of specific disease states, discover potential therapeutic candidates and evaluate product candidates in clinical trials. Regeneron has developed several proprietary platform technologies, which it has incorporated into a comprehensive system that allows it to accelerate the discovery and design of fully human antibodies and move these candidates rapidly into clinical development. The successful Director of CMC Regulatory Affairs will be a thought leader and actively counsel and guide lOPS decision-making and strategic planning. Roughly 30% of work time will be cosurned by this goal. Duties and Responsibilities: *Leading, maintaining, and coordinating all CMC filings and actively supporting all CMC touching filings within the business. *Roughly 50-60% of work time will he consumed by this goal, This role will also include some writing/editing, as well as direction of others in these tasks. *Acting in a consultative capacity to lOPS as day-to-day and annual decisions and processes arc executed. In this capacity, the successful candidate will ensure lOPS decisions are conforming with current and anticipated agency requirements. Roughly 10-20% of work time will be consumed by this goal. Specific responsibilities will include: *VEGFT Eye I3LA and MAA 50% (note: incumbent will handle gout arid aflibercept) *Assist with the scientific writing and review of a ELA (eCTD) and evaluate conformance with the regulatory requirements. *Manage timelines in cooperation with project management and plant management. Provide progress updates to senior management *Coordinate and manage regulatory inspections at the Rensselaer site or at other sites if the inspection relates to CMC issues. *In conjunction with Regulatory Development, responsible for direct communications with the agencies on all CMC related issues and responsible for ensuring implementation of commitments made and implied by those interactions with respect to CMC and CMC impacted issues. *S-a projects (note: RE0N475, 668, 421, Ang2, and 50% of NMEs) *Assist with the scientific writing and review of 1ND, IMPDs, and their amendments and evaluate conformance with the regulatory requirements. *Manage timelines in cooperation with project management anti plant management. Provide progress updates to senior management in conjunction with Regulatory Development, responsible for direct communications with the agencies on all CMC related issues and responsible fo ensuring implementation of commitments made and implied by those interactions with respect to CMC and CMC impacted issues.

Job Title: Manager, Regulatory Affairs Company: Cornell University Location: Ithaca, NY Description: Job details Req ID 41171BR Business Title Manager, Regulatory Affairs Business Global Reg Affairs/Pharmacovig Sub-Business Medical Devices Country United States State/Province Illinois Location of Position Deerfield, IL Shift_ 1st Job Description Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations Represent or lead the RA function on assigned cross-functional project teams Monitor applicable regulatory requirements; assure compliance with Baxter and external standards Establish appropriate communication within RA and other functions primarily at project level Perform gap analysis and propose solutions Develop and document sound regulatory decisions and justifications Ensure project teams and business objectives and deliverables are aligned with regulatory strategy May provide direct supervision of individuals May review promotional material or SOP??s for compliance with local and global regulations Job Requirements Sound basis of Regulatory knowledge Documented 510(k) submission experience Scientific Knowledge Ability to manage complex projects and timelines in a matrix team environment Strong oral and written communication and presentation skills Demonstrated interpersonal skills including strong negotiation skills Ability to independently identify compliance risks and escalate when necessary Ability to lead and coach others Bachelor??s degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects. Higher degree/PhD will be an advantage. Percent Travel Required 5% Index Monitor