Global Head/Executive Director, Regulatory Affairs – Permanent – New Jersey

Proclinical is seeking a Global Head/Executive Director, Regulatory Affairs for an innovative global biopharmaceutical company located in New Jersey.

Primary Responsibilities:

In this role, you will define the regulatory strategy for all products currently in the portfolio at various phases, to ensure the correct implementation of the regulatory strategy, to evaluate the regulatory impacts of potential new products, and to define the regulatory guidelines.

The position is based in New Jersey in a hybrid work schedule.

Skills & Requirements:

• 10+ years of Regulatory Affairs or related experience in the pharmaceutical industry. Advanced degree (PharmD, PhD) preferred.
• Global Regulatory Affairs experience with deep expertise in US FDA interactions and negotiations. EU regulatory experience is ideal.
• Experience with developmental and commercial products.
• People leadership experience while leading regulatory filings to FDA and other health authorities.

The Global Head/Executive Director, Regulatory Affairs will:

• Define the regulatory strategy for the entire Group in line with the strategic plan, the guidelines of Corporate Management, and the management of the departmental budget.
• Ensure the correct implementation of the regulatory strategy through the guidance and supervision of all regulatory activities (registrations, responses to authorities, etc.) at the Group level, intervening directly where necessary due to complexity.
• Ensure, through the coordination of the appointed Senior Specialists, the correct registration of new Marketing Authorization Applications (MAA) and variations up to the level of the "Core Submission Package", the management of any requests and Deficiency Letters, and the publication and confirmation by the authorities.
• Ensure Life Cycle Management for all products of the Group up to the submission of the variation package, the management of any Deficiency Letters, and the communication of the approval.
• Ensure the correct management of the CMC Documentation through the supervision of activities on new projects, responses to any Deficiency Letters, and management of variations.
• Ensure, by coordinating the Specialists, the correct and timely publishing activities and the creation and management of internal databases.
• Ensure, collaborating with Corporate Management and other key stakeholders, the activities of Regulatory Due Diligence in case of M&A and acquisition of products in the different stages of development.
• Monitor regulatory changes in the contexts where the products are registered, evaluate the regulatory impacts and plan any necessary actions, also involving other business areas.

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or .

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.