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Regulatory Scientist, Global Regulatory Affairs
Requisition ID: 2698180206
Research & Development, LLC., a member of Johnson & Johnson's Family of
Companies, is recruiting for a Regulatory Scientist, Global Regulatory
Affairsin the Oncology Therapeutic area based in Raritan, NJ.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Regulatory Scientist provides support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy. Key responsibilities include the following and may vary based on job level and regional responsibility:
- Participate in global regulatory team meetings as appropriate
- Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
- Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
- Act as back-up for contact with Regulatory Agencies as needed;
- Draft cover letters for Regulatory Agency communication
- Assist in the preparation of meetings with Regulatory Agencies
- Liaise with LOCs, and ensure responses to queries are made in a in timely manner, and that content is consistent with the regulatory strategy
- Assist in development and improvement of processes related to regulatory submissions
The Regulatory Scientist will review clinical trial plans and protocols and ensure alignment with regulatory requirements; Provide regulatory support throughout registration process and life-cycle management; Advise team in required documents and submission strategies (in collaboration with LOCs as appropriate). Assist with timely availability of submission documents and ensure that all document components are in place on time; Draft and review some document content (depending on level of regulatory knowledge/expertise); Prepare, hold and lead cross functional team meetings as appropriate; Understand submission details and liaise with Submission Management; Review and approve submission plans; Review of submission documents to ensure compliance with regulatory requirements; Assist with submission and acceptance of the submission package; Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans. Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints; Serve as the Regulatory representative on specific multi-discipline teams; Keep abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidance’s and requirements related to those areas.
- An advanced degree (MS, Pharm D, PhD) is highly preferred, a minimum of a Bachelor’s Degree is required.
- 1+ year relevant experience with an advanced degree OR 4+ years with a Bachelor’s Degree is required.
- Pharmaceutical industry experience is preferred.
- Oncology Drug Development experience is a plus.
- Understanding of the drug development process is required.
- Understanding of the regulatory submission and approval process is required.
- Knowledge of the regulatory environment, US guidelines and practices is required.
- Direct experience in regulatory affairs is desirable.
- Candidate must be able to work successfully within a team environment and as an individual contributor.
- Project management, oral & written communication skills, organization and multi-tasking skills are required.
This position is located in Raritan, NJ and may require less than 10% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)