Director Of Regulatory Affairs Jobs in New York

Job Title: Director Regulatory Affairs Company: Cambridge Group, a part of On Assignment Location: White Plains, NY Description: The Director Regulatory Affairs is responsible for integrating and applying knowledge of global regulations governing pharmaceutical drug development to all aspects of the company's preclinical and clinical drug development programs, policies, and procedures, to ensure the rapid and successful development and registration of company products while maintaining compliance with all regulatory requirements and commitments. Lead multidisciplinary teams on the content, format, style and architecture of marketing applications (BLAs and MAAs) and the strategies for gaining regulatory approval. Write and/or review eCTD sections and evaluate relative to stratgegy and for conformance with the regulatory requirements.Contribute 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. Contribute to multidisciplinary teams on the regulatory requirements for publically shown materials, including promotional materials. Lead multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application, Clinical Trials Application (CTA) and the IMPD. Act as liaison with competent regulatory authorities on routine matters and serve as the company lead for regulatory meetings with agencies. Supervise the preparation of IND (or CTA) amendments, annual reports and other routine regulatory submissions. Write and/or review more strategic regulatory submissions such as briefing packages for FDA meetings or EU scientific advice procedures. Review critical analyses of data (clinical, preclinical and manufacturing) and independently develop interpretations and conclusions. Perform meaningful reviews of clinical/preclinical/manufacturing protocols and studies reports. Manage the performance and development of staff. Lead training on applicable requirements for scientific staff as required. 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. Must be able to work independently with all levels of management internally and externally under minimal supervision of the department head. Must have team leadership experience, participate 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.Please refer to job code SD6905 when responding to this ad.

Job Title: Director, Regulatory Affairs (CMC) Company: Regeneron Pharmaceuticals, Inc. Location: Rensselaer, 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: Associate Director Regulatory Affairs Company: Cambridge Group, a part of On Assignment Location: White Plains, NY Description: Associate Director Regulatory AffairsReporting to the Director, Regulatory Affairs, the successful candidate will direct and prepare documentation in accordance with the highest regulatory standards for submission to regulatory agencies, with an emphasis on US FDA in the small molecule area. This person will be detail-oriented and will have a solid working knowledge of cGLP, cGCP cGMPs, and eCTD NDA experience in regulatory affairs. The candidate should be a proven leader with the ability to establish regulatory policies and strategies in full compliance with all applicable regulatory requirements. He/she will serve as the regulatory representative on relevant project teams, and as the regulatory contact with FDA for small molecule projects, as needed. The Associate Director, RA will manage submission activities for assigned projects by collecting, preparing, reviewing and assembling documentation, as necessary, for new INDs, IND amendments, annual reports, meeting briefing packages and NDA submissions and supplements. The Associate Director, RA should be able to work in a small company environment and therefore must be facile and adept at balancing work. He/she should possess a solid knowledge of current regulatory requirements and ensure that changes in regulatory requirements that can affect the company's business are appropriately communicated to project teams and senior management. He/she will coordinate effectively with appropriate functional groups in identifying and obtaining documentation and information for regulatory submissions in a timely manner. The Associate Director, RA, will work with contractors and consultants, as needed. The candidate will be expected to develop and manage regulatory timelines as well as have the ability to multi-task. This person will also assist in the daily departmental activities by assigning and monitoring the work of staff in the small molecule area. Interacting with Clinical Research, Preclinical Development and other functional groups to ensure regulatory compliance is essential. Experience in eCTD NDA requirements and post-marketing activities is required and essential. Experience in antibodies, vaccines or gene therapy is desirable, but not essential. The strongest candidate will have at least 8 to 10 years experience in all aspects of regulatory affairs, in a pharmaceutical or biotechnology environment with an educational background in the life sciences. Candidates must have a proven track record of effective collaboration with the FDA from filing INDs through NDA post-approval. Experience with antibodies is a plus. Candidates must be highly knowledgeable regarding global regulations, particularly FDA and EMEA. Exceptional communication (verbal, written, listening), relationship building and influencing skills with the ability to communicate across multiple disciplines successfully and accurately, both internally and externally, is required. Excellent writing and presentation skills, with attention to detail and accuracy is needed. Able to adapt to changing priorities. Thorough understanding of drug development and post-marketing activities, including CMC, preclinical, clinical development and labeling. Knowledge of biologics/biotech product is an asset. Candidates must demonstrate ability to manage staff. Experience with preparation of electronic drug submissions, i.e. eCTD NDA, is required and essential to the position.Please refer to job code SD7099 when responding to this ad.

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: Director, Regulatory Affairs Company: Regeneron Pharmaceuticals, Inc. 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.

Job Title: Associate Director Regulatory Affairs – Latin America Company: Klein Hersh International Location: New York, NY Description: Associate Director Regulatory Affairs Latin America My client is a worldwide leader in the manufacturing, research and development and marketing of innovative products. Their success is based on a commitment to creating and maintaining long-term customer relationships, strong leadership and consistent innovation around new products. As one of the top consumer health companies worldwide, my client is looking to add this key member to their OTC team. If you are an ambitious professional and meet the criteria below, this may be the position to further enhance your career. Job Responsibilities: Support Latin America and Consumer Health Business initiatives Develop, Implement and Maintain Regulatory Affairs strategies for new/existing products in 25 countries. Compile Regulatory submissions Liaise with Latin American Affiliates, manufacturing operations and project teams. Ensure GMP-related documentation is in conformance Liaise between plants and regulatory groups Requirements: Job Requirements: B.S. Degree: Master's or PhD degree preferred Minimum 7 years experience in Regulatory Affairs OTC environment Minimum 3 years people and international management experience Minimum 3 years hands-on CMC and international submission experience Strong knowledge of pharmaceutical development process In-depth understanding of cGMP's, Latin America Regulatory requirements Fluent in English and Spanish or Portuguese 25% travel required For confidential consideration, please forward your resume in a Word document to Register to View only qualified candidates will be contacted. Visit www.kleinhersh.com to view other job opportunities available through our company.

Job Title: Manager Regulatory Affairs Company: Regeneron Pharmaceuticals, Inc. 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: Manages staff responsible for integrating/ applying knowledge of global regulations governing pharmaceutical drug development to all aspects of Regeneron's preclinical and clinical drug development programs, policies, and procedures, so that the necessary state of compliance is maintained relative to all regulatory commitments. Essential Duties and Responsibilities include, but are not limited to the following: *Provides guidance to multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application. *Assists with and approves writing, review and preparation of IND amendments, annual reports and other regulatory requirements. *Provides guidance to multidisciplinary teams on the content, format, style and architecture of a Biologics Licensing Application (BLA). Assists with the scientific writing and review of BLA and evaluates conformance with the regulatory requirements. *Performs critical analyses of data (clinical, preclinical and manufacturing) and independently develops interpretations and conclusions and prepares technical reports. Performs meaningful reviews of clinical/preclinical/manufacturing protocols and studies reports. *Participates in multidisciplinary project teams to provide regulatory guidance and communicates regulatory goals. *Manages staff responsible for assisting with implementation of a 21 CFR Part 11 compliant electronic document management and regulatory e-submission system and staff responsible for editing scientific sections of the IND application against regulatory requirements. *Manages the performance and development of staff. Provides training on applicable requirements for scientific staff as required. *Works independently with all levels of mgmt internally and externally under the general supervision of the department Associate Director. Normally receives no instructions on routine work assignments and minimal instructions on project assignments. *Typically reports to Director or above. Provides day to day work assignments. Participates in hiring, termination and disciplinary process. Write and conducts annual performance reviews. Trains and guides staff in their work assignments.

Job Title: Associate Director, Regulatory Affairs KL Biopharmaceutical company Company: New York's Job Exchange Location: White Plains, NY Description: Associate Director, Regulatory Affairs KL Register to View Biopharmaceutical company Job Description Associate Director, Regulatory affairsReporting to the Director, RA, the successful candidate will direct and prepare documentation in accordance with the highest regulatory standards for submission to regulatory agencies, with an emphasis on US FDA in the small molecule area. This person will be detailoriented and will have a solid working knowledge of cGLP, cGCP cGMPs, and eCTD NDA experience in regulatory affairs. The candidate should be a proven leader with the ability to establish regulatory policies and strategies in full compliance with all applicable regulatory requirements. Heshe will serve as the regulatory representative on relevant project teams, and as the regulatory contact with FDA for small molecule projects, as needed. The Associate Director, RA will manage submission activities for assigned projects by collecting, preparing, reviewing and assembling documentation, as necessary, for new INDs, IND amendments, annual reports, meeting briefing packages and NDA submissions and supplements. The Associate Director, RA should be able to work in a small company environment and therefore must be facile and adept at balancing work. Heshe should possess a solid knowledge of current regulatory requirements and ensure that changes in regulatory requirements that can affect the company s business are appropriately communicated to project teams and senior management. Heshe will coordinate effectively with appropriate functional groups in identifying and obtaining documentation and information for regulatory submissions in a timely manner. The Associate Director, RA, will work with contractors and consultants, as needed. The candidate will be expected to develop and manage regulatory timelines as well as have the ability to multitask. This person will also assist in the daily departmental activities by assigning and monitoring the work of staff in the small molecule area. Interacting with Clinical Research, Preclinical Development and other functional groups to ensure regulatory compliance is essential. Experience in eCTD NDA requirements and postmarketing activities is required and essential. Experience in antibodies, vaccines or gene therapy is desirable, but not essential.Job Requirements :The strongest candidate will have at least 8 10 years experience in all aspects of regulatory affairs, in a pharmaceutical or biotechnology environment with an educational background in the life sciences. Candidates must have a proven track record of effective collaboration with the FDA from filing INDs through NDA postapproval. Experience with antibodies is a plus. Candidates must be highly knowledgeable regarding global regulations, particularly FDA and EMEA. Exceptional communication verbal, written, listening, relationship building and influencing skills with the ability to communicate across multiple disciplines successfully and accurately, both internally and externally, is required. Excellent writing and presentation skills, with attention to detail and accuracy. Able to adapt to changing priorities. Thorough understanding of drug development and postmarketing activities, including CMC, preclinical, clinical development and labeling. Knowledge of biologicsbiotech product is an asset. Candidates must demonstrate ability to manage staff. Experience with preparation of electronic drug submissions, i.e. eCTD NDA, is required and essential to the position. A benefit package may or may not be available. Request specific information from the employer. Job Summary Company Job ID: 52086322 Job Title: Associate Director, Regulatory Affairs KL Company: Biopharmaceutical company Location: US - NY, WHITE PLAINS, 10610 AJE Reference Number: 536883340 Job Start/End Date: not provided Job Type: Regular Job Classification: Full Time Hours/Week: not provided Salary Range: not provided N/A Education: not provided Required Degree/ Formal Training: not provided Required Licenses/ Certificates : not provided Experience: not provided Company Homepage: not provided More Information About AJE Overview Team Blog Press Partners Contact Sitemap Employers Why AJE? Products OFCCP Policy Post Jobs Search Resumes Advertise Link To Us Help Job Seekers Search Jobs Post Resume Sign Up For Job Scout Resume Writing Tips Cover Letter Help Career Articles Salary Tools Help Legal Terms and Conditions Privacy Disclaimer Security Notice