Director Of Regulatory Affairs Jobs in North Carolina

Job Title: Manager, Regulatory Affairs Company: Novartis Corporation Location: Princeton, NC Description: *** THIS POSITION IS LOCATED AT OUR WILSON, NC FACILITY ***The manager, regulatory affairs will supervise the regulatory operations team andmanage activities associated with the submission of Regulatory documentation to FDA(specifically post approval maintenance documents).RESPONSIBILITIES:Develop best practices for Regulatory Affairs in conjunction with established Sandoz regulatory procedures. Collaborate with other departments and regulatory groups within Sandoz to establish practices based on the functional area business processes. Provide leadership to the teams to ensure quality submissions.Represent Wilson RA regulatory staff reporting to Director Regulatory Affairs.Supervise and participate in the preparation of ANDAs.Insure appropriate implementation and usage of electrnic documentation and submission system to FDA.Assess proposed manufacturing changes and provide strategic regulatory guidance through change control mechanisms.Supervise and review the preparation of post approval submissions such as a PAS/CBE-30/CBE-0 supplements for an ANDA.Establish, update, implement, and provide training on Regulatory required formats, policies, standards, and procedures for regulatory submission documentation. Defining high quality processes and preparation of documentation (i.e. SOPs and work instructions) in accordance with established Sandoz regulatory practice.Provide regulatory advice to technical operations departments based on knowledge of current requirements and conduct training sessions.Manage RA staff members and contribute to the development of the team.Direct even workflow distribution to the team. Routinely interact with FDA and other regulatory authorities for approved products.Ensure compliance with labeling guidelines and supervise labeling procedures at the Wilson site.SUPERVISORY:This position has supervisory responsibilities and reports to Director Regulatory Affairs.Minimum requirementsGood conflict resolution and problem solving skills. Strong interpersonal skills and matrix management skills. Demonstrated personnel management skills. Excellent written and verbal skills and the ability to communicate clearly, concisely and effectively. Will be an open, available, transparent communicator with good leadership and presentation skills and ability to influence. Will have high energy level and will adhere to high ethical standards.PHYSICAL DEMANDS: The physical demands of this position are consistent with those expected in an office/administrative environment. Typical activities may include work at a computer, copying, scanning, filing and, dependant on the position, considerable time may be spent sitting, standing or walking. Light lifting (up to 10-15 lbs) may be required from time to time, consistent wtih an office environment.QUALIFICATIONS:Demonstrated track record submitting and maintaining pre and post approval regulatory dossiers to FDA.Experience with Office of Generic Drugs and ANDAs a plus.Experience dealing with compliance issues addressed by health authorities.Expertise in the areas of cGMPs and GLPs.Minimum of a Bachelors degree in a scientific discipline with minimum 6 years of pharmaceutical regulatory experience.Physical Demands: The position requires close vision. The position requires distance vision.Work Environment: The noise level is usually moderate.

Job Title: SR. DIRECTOR REGULATORY AFFAIRS AND QUALITY SYSTEMS Company: Oncomethylome Sciences S.A. Location: Durham, NC Description: COMPANY OVERVIEWOncoMethylome is a molecular diagnostics company developing gene methylation tests for early detection of cancer and for personalized treatment decisions. The company is committed to providing treating physicians with novel, accurate, and informative diagnostic tools.Approximately half of all men and one third of all women develop cancer during their lifetime. Without exception, one of the best ways to survive cancer is to detect it early when it is still confined to the organ of origin and is therefore most effectively treatable. OncoMethylome is developing novel molecular tests for detecting cancer when it is still in early stages of growth. In addition, OncoMethylome's personalized treatment products, which analyze the molecular make-up a patient's tumor, are designed to provide the treating physician with additional information about the patient's cancer, at the time of diagnosis, for use in selecting the most appropriate course of treatment.OncoMethylome was founded in 2003, is headquartered in Belgium, and has offices and laboratories in Belgium, and in Durham, NC, USA.For additional information please visit www.oncomethylome.com.TITLESr. Director Regulatory Affairs and Quality SystemsLOCATIONDurham, NCREPORTING RELATIONSHIPReporting to the COODESCRIPTIONThe Sr. Director of Regulatory Affairs and Quality Systems will develop and lead the oversight of the companies' Regulatory Affairs and Quality Assurance programs. The individual will lead the development and execution of the companies' molecular diagnostic regulatory strategy, including the spearheading of the companies' CLIA, FDA, ASR, RUO, IUO, and international IVD kits and services submissions. Additionally the individual will develop and implement the Design Control process to in compliance with regulations, guidelines, and operating procedures. The individual will also develop and manage QA and regulatory oversight of projects, assignments, and training; including conducting independent internal and partner audits to assess compliance with regulations, guidelines, and operating procedures. The individual will also design, implement, and oversee the company's document control system. Experience with molecular diagnostics assays and technology, formalin-fixed paraffin embedded and fresh tissue, DNA and RNA extraction, statistical analysis, and signature development in both predictive chemotherapy response and pathway activation will be helpful in this role. Qualifications:COMPENSATIONAn appropriate financial package will be developed for the successful candidate to include a competitive base salary, and bonus opportunity based on performance.QUALIFICATIONSUniversity Degree in Life Sciences is required, preferably in Cell and Molecular Biology, Biochemistry, or related disciplines.Candidate must have 7 years minimum experience in leading or managing successful regulatory and/or quality assurance initiatives/projects/departments.Experience and knowledge of regulatory processes.Superior oral and written communication skills along with the ability and tenacity to move major initiatives forward with a focused effort and clear set of business goals.Excellent leadership skills, hands-on style, strong work ethic and an interpersonal style that will be compatible with the Company board and corporate management teams. Must be challenging and demanding of everyone around them with a manner that creates a team-building environment.Proven track record managing a comparable business with knowledge of worldwide diagnostic or life sciences markets including regulatory environment and technology sources.Prior significant involvement in strategic planning, business development, and licensing is highly desirable. Should be actively involved in a growth environment where demonstrated results in these areas are evident.Should possess a high degree of comfort with marketing and commercialization and be at ease with technology and finance.SCOPE OF ACCOUNTABILITYDevelop regulatory and clinical strategies and implementation plans, in partnership with the COO, that achieve the Company's strategic goals, including in particular, establishing the Company's products and methods as standard of care in all target markets. Oversee implementation of all such plans to successful conclusionImplements and maintains the effectiveness of the Quality System.Responsible to establish a service laboratory in compliance with ISO, CLIA and CAPResponsible for Design Control process to ensure that US FDA and ISO Quality System requirements are met on a consistent basis.Primary contact with regulatory agencies for compliance and global product registrations. Primary interface with the FDA inspectors, ISO, vendor and partner auditors. Lead for internal and external audits and responsible for follow-ups/corrective actions within specific timeframe. Manages FDA submissions, including Pre-IDE meeting planning, follow ups, and inspections.Works with R&D (System development and assay development) and Sales & Marketing to develop plans that are in line with regulatory requirements in US, Canada and Europe.Ensures consistent levels of compliance, internally and externally when applies, throughout development, manufacturing and distribution of The Company's products. This includes but not limited to formal documentation, vendor/manufacturing qualification, on-site inspections and audits, CAPA, and risk management. Manages the review and final approval process of all products advertising and labeling to determine compliance with global labeling requirements.Hires and works with external consultants, as far as necessary, to achieve regulatory aspects of the business goalsWill work closely with Pharmaceutical companies to support the implementation of the Companion Diagnostics of OncoMethylome.Other quality, clinical or regulatory associated tasks.Should spend considerable time in Europe.DESIRABLE TRAITS AND SKILLSStrong interpersonal and presentation skills, inclusive of experience presenting to regulatory bodies and at technical conferences.Extensive knowledge of diagnostic and pharmaceutical research and development processes, GCP and the regulatory environments.Ability to work and cooperate with outside companies ( such as service labs and pharmaceutical companies) in a team approach to make sure the regulatory aspects for OncoMethylome will be covered.Knowledge of word-processing, spreadsheet, and database applications.Knowledge of bio-informatics.Considerable knowledge of quality assurance processes and procedures.Excellent problem solving, risk analysis and negotiation skills and exceptional training capabilities.Effective organization, communication, team orientation, and leadership skills.Ability to work independently with initiative and ability to manage multiple projects.Ability to establish and maintain effective working relationships with coworkers, managers and clients.Management of staff overseas.

Job Title: Associate Director, Regulatory Affairs Company: Talecris Plasma Resources Location: Research Triangle Park, NC Description: Want a career where you can change lives? Are you looking to make a difference? At Talecris Plasma Resources, we specialize in changing lives. Our business is collecting human plasma used in therapies that help people maintain and enhance their quality of life. Thanks to continued growth, we have an immediate, full-time opening for an Associate Director, Regulatory Affairs at our headquarters in Research Triangle Park, NC. In this position you will be a liaison to regulators on all matters regarding Talecris Plasma Resources and provide direction to and negotiate with FDA, CLIA/COLA, GHA, and state specific agencies to obtain pre-clearance of actions and manufacturing of products, respond to FDA regulatory letters and take action on competitor behavior to support TPR strategy. Other responsibilities include: Directing reviews and analysis of, evaluating and providing regulatory guidance for content of TPR materials to assure quality, fair balance, appropriateness and accurate labeling of TPR products in compliance with FDA regulations Managing the investigation and audit of advertising and promotional activities to assure all materials in use comply with the FD & C Act, FDA regulations, and company SOP's Managing submissions to FDA as required by regulation Managing the coordination and interaction with domestic and international marketing and regulatory counterparts to obtain input regarding the regulatory considerations and decisions to formulate product strategy consistent with Talecris products BS with 20 years of experience or an MS degree in life sciences, biologics preferred with 10-12 years of proven regulatory experience with a consistently good performance record or a Ph.D., Pharm D, or MD or equivalent education with at least 4-6 years industry/FDA regulatory experience or Complete knowledge of, and expertise in interpretation of, the FD & C Act, FDA Code of Federal Regulations and Prescription Drug Marketing Act especially for advertising, promotion, labeling, sample distribution, and scientific & educational activities is essential. In-depth experience in pharmaceutical business with knowledge of existing product line is desirable. Extensive experience and excellent interpersonal skills are required as the incumbent must be able to knowledgeably discuss, negotiate and effectively deal with legal product concerns and regulatory issues pertaining to advertising and promotion and other labeling. Effective oral and written communication skills are critical to deal professionally with sensitive issues involving Talecris, and FDA staff at various levels concerning promotional activities. Competence to provide regulatory decisions and direction to marketing regarding strategy for advertising and promotional activities is a must, including ways to diffuse competition. We offer a competitive compensation and benefits package and excellent work/life balance. To apply please visit: www.talecrisplasma.com and search Job ID #5476. Indicate salary requirements. No relocation provided. (No phone calls or agency referrals, please) EOE M/F/D/V

Job Title: Director of Regulatory Affairs Company: The Wellington Group Location: Raleigh, NC Description: The Wellington Group is seeking an experienced regulatory affairs professional for an exciting new medical device / combination therapy position. Excellent opportunity to help bring new medical devices to the global market!The Director of Regulatory Affairs is a key role in the development, research and commercialization of new products and the management of regulatory and quality disciplines for the organization. The Director will ensure that the company complies with applicable global regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products. Responsibilities include: Lead a team of regulatory professionals to define and implement the regulatory strategy Lead the preparation, submission, and timely approval of regulatory applications Lead the interaction and negotiations with regulatory agencies Maintain regulatory procedures and documents to maintain approvals and certification for development, manufacturing, and marketing of products Inform senior management of regulatory requirements and status of products and significant regulatory issues/trends

Job Title: Global Regulatory Affairs Manager, Bt Soybean Company: Bayer Location: Research Triangle Park, NC Description: Bayer CropScience (BCS) is one of the worlds leading innovative crop science companies in the areas of crop protection, non-agricultural pest control, seeds and plant biotechnology. With our headquarters in Monheim, Germany, Bayer CropScience has a global workforce of about 17,900, and is represented in more than 120 countries. BCS is structured into six Business Operations units: four regional crop protection units and two units responsible for Environmental Science and BioScience offering an outstanding range of products and extensive service backup for modern, sustainable agriculture as well as for non-agricultural applications.Job description The primary responsibility of this role is to lead the establishment of regulatory studies, creation of regulatory documents and development of regulatory strategy to achieve regulatory clearances worldwide expediently and consistently within overall business objectives for Bayer CropScience (BCS) BioScience group.The incumbent will: Develop the registration strategy, including the data requirements, costs and time schedules necessary to achieve global product approvals as required by the project plan in a timely and cost-effective way acting as an interface between Portfolio Management (being core team members in Project/Product teams) and Development functions to ensure strategic direction is aligned with agreed business goals. Develop and maintain the global core dossier for the identified product(s) and, support the Local Registration Managers in adapting it as may be required locally to obtain desired permits and authorizations. Ensure the provision of robust scientific information to support key internal regulatory project milestones (e.g., including predictive safety assessments for first field trial release and registrability profile for projects and products; fulfillment of launch policy; discontinuation decision and related planning, etc). Serve as world-wide technical expert, on relevant regulatory issues potentially impacting the identified product. Defend BCS approach at local, regional or international forums where science-based harmonized approaches may be influenced and promoted. Propose, in line with the business timelines, the 1-5 year regulatory studies and activities budget, specifying quality standards to be met, and making best use of BCS resources. Contribute to the creation and updating of robust Project Plans and whenever required, provide feedback to such teams on achievements and bottlenecks. Support regional and local Registration Managers in responding to government authorities. Evaluate new safety information (publicly or privately derived) potentially impacting product approvals and propose response plans to ensure BCS business opportunities are maintained. Fulfill BCS and government reporting requirements. Travel internationally and domestically, as needed, approximately 25%.

Job Title: Sr Manager, Regulatory Affairs Company: Biogen Idec Inc Location: Research Triangle Park, NC Description: This position is in the Regulatory CMC group and is focused on the development of biologics. Responsibilities include actively contributing to the development and implementation of CMC regulatory strategy for specific projects including identifying and assessing regulatory risks, serving as the regulatory representative on project teams, serving as the regulatory contact with relevant regulatory authorities,and coordinating all CMC aspects of regulatory submissions.Qualifications Minimum 5+ years pharmaceutical/biotechnology industry experience, 2 years regulatory experience working on biologic programs. Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals. Demonstrate excellent communication skills. Ability to represent the department in project teams. Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload. Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff. Experience in interfacing with relevant regulatory authorities. Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements. Knowledge and understanding of applicable regulations. Computer literate.EducationBA/BS/University degree required, Life/Health Sciences preferred.

Job Title: Director of Regulatory Affairs - New Drugs - Specialty Pharmaceuticals Company: Covidien Location: Raleigh, NC Description: Candidates must reside within the Raleigh North Carolina area as no relocation assistance is provided for this opportunity.The position of Director of Regulatory Affairs, in the Regulatory Affairs Department, requires an individual with direct regulatory affairs experience and experience managing a group of regulatory professionals in the development of new drug development programs. This person will be responsible for the formation of the global regulatory strategy involving the direction and management of resources and activities in the development and implementation of regulatory strategies leading to the rapid submission and approval of high quality dossiers meeting the requirements of Health Authorities and the needs of the company;ESSENTIAL FUNCTIONS:1. Maintains current high level knowledge of regulations, the regulatory process, and the application of regulations to assigned products - expands regulatory background through work on projects, researching available documents and attending relevant training. Anticipates how future developments in the regulations for relevant therapeutic areas may effect drug development process.2. Liaison with regulatory agencies during the development process and for assertively and successfully prosecuting marketing applications to ensure their timely approval.3. Oversees those activities that lead towards the submission of high quality clinical trial applications, which meet clinical development timelines.4. Directs resources and assures that activities will lead to the provision of adequate and proactive regulatory guidance into the Core Development Teams for new product development to ensure that the resultant development package is consistent with ICH guidelines and global regulatory agency expectations for new products.5. Interacts with key functions of the company including R&D, Clinical Development, Manufacturing, Quality Assurance and Marketing.6. Responds to inquiries from various departments regarding regulatory strategy, post-approval changes, etc. in a timely manner. Insures proper research was conducted prior to communicating regulatory strategy.7. Drafts, circulates, and maintains department work instructions of essential job functions. Insure compliance with procedures among staff.8. Develops coaching partnerships with direct reports. Provides training and development plans. Generates team goals and manages yearly progress of goal completion. Provides reports with challenging assignments and opportunities to address their development needs. Provides continuous feedback and end-of-year performance review. 9. Provides training in various RA areas, including but not limited to: documentation review, EZSubs utilization, SOPs, work instructions, submission procedures, timeline management, regulatory procedures, FDA application types, review process, etc. Develops training programs for new department members. 10. Performs due diligence on Regulatory information for external collaboration projects. Provides regulatory strategy and support to contact manufacturers and partner companies, as necessary. Provides templates for document authoring and directs timeline, as appropriate.11. Assists plant site RA with regulatory issues. Serves as liaison to site RA and QA personnel for product life cycle management. Provides regulatory requirement support and direction as necessary. Provide assistance during FDA audits as necessary.12. Manages those activities that lead towards the submission of high quality CMC applications, facilitating pharmaceutical and clinical development timelines.

Job Title: CMC Manager - Regulatory Affairs BHJOB3594_271 Company: Location: Hickory, NC Description: The Wellington Group has been engaged to find an experienced CMC Manager to be part of the Regulatory Affairs group for a growing and profitable biologics, pharmaceutical and animal health company. Put your RA expertise to work today in a great new job! The CMC Manager will support the Director in the management of CMC-related submissions to FDA and other regulatory authorities worldwide. The CMC Manager will assist in the development and execution of CMC regulatory strategies and regulatory submissions (IND, BLA, etc.) for company products. They will manage CMC post approval changes for US and International marketed products. Responsibilities include: ? Prepare CMC regulatory documents based on technical information from R&D/Operations/Quality for submission to FDA, USDA, and (where applicable) international regulatory authorities ? Prepare CMC submissions for IND, BLA and post approval CMC supplements, and supports their approval by regulatory authorities ? Participate in meetings on CMC regulatory issues at the request of the Director of Regulatory Compliance ? Track, maintain and coordinate multiple CMC project timelines and coordinate on-going activities across multiple functions ? Maintains awareness of and expertise in cGMPs and CMC related regulations and guidelines. ? Manage Change Control process Company is motivated to hire ASAP! The qualified candidate will have: ? Bachelor?s degree in a scientific discipline or equivalent. ? Minimum of 3-5 years experience in pharmaceutical industry. Minimum 3 years experience in CMC and qualifying quality assurance role is required. ? Knowledge of cGMP/FDA regulations ? Knowledge of US and/or international CMC regulatory requirements ? Experience with biologics is desirable. ? Strong teamwork, interpersonal skills and communication skills are essential ? Proficient in MS Office applications. Industry: Biologics, Veterinarian Medicine, Biotechnology, Pharmaceuticals, USDA, CMC Submissions Job Code: BHJOB3594_271 Recruiter: Heather Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance. Don?t wait, apply with The Wellington Group today! (all information will be held in the strictest of confidence) The Wellington Group ( http://www.twgrecruiters.com ) Register to View

Job Title: Executive Director, Regulatory Affairs Company: Pharmaceutical Product Development, Inc. Location: Morrisville, NC Description: The Executive Director, Regulatory Affairs provides direct management and support to members of Regulatory Affairs Development. Responsible for all budgets and contracts in relation to their assigned projects. Executive contact for the sponsor. Provides regulatory advice on strategy and manage projects in the provision of regulatory affairs services. Acts as liaison with internal and external clients in the provision and marketing of these services. Oversees/ensures all aspects of Regulatory Affairs are conducted in accordance with sponsor companies requirements.This position primarily ensures the day to day operation and management of assigned regulatory services, in accordance with contract, all applicable regulatory requirements and laws, and sponsor/PPD polices and procedures. Works globally to develop new business and to deliver existing business in order to meet PPDs business goals.

Job Title: Regulatory Affairs Manager Company: Becton Dickinson Location: Durham, NC Description: This associate will be responsible for the management of regulatory product submissions from the strategic planning stages through conduct of clinical trials and submission to FDA and/or international regulatory agencies. Provide regulatory input on all advertising and promotional material for US and international markets.Principal Accountabilities:Manage planning and preparation for regulatory submissions (510(k), PMA Supplements, and other regulatory documentation) for product approvals to the FDA and international governmental agencies, including requisite post-market approval reports. Assure regulatory body submissions are prepared and processed in a proactive manner.Assist in the planning and design of clinical studies in support of FDA Pre Market Approvals (PMA, 510K clearances, post-market studies, and internal studies (including feasibility studies) as required.Help to oversee regulatory registrations and submissions for commercialization in US and ex-US countries.Assess engineering changes for impact to product approvals, including review and approval of engineering change requests.Assist in the development of policies and procedures which provide direction to Company on regulatory requirements in support of Product Development.Maintain proactive and positive working relationships with internal and external customers, both US and Ex-US, as assigned by the Sr. Director of Regulatory Affairs, to ensure the Company is positioned to meet strategic corporate goals.Job Dimensions:Responsible for providing regulatory input on decisions regarding product development cycles and key member of US and ex-US regulatory strategy teams.