Senior RA Manager/Associate Director

Proclinical is currently recruiting for a Senior Manager/Associate Director of Regulatory Affairs Strategy with a leading biopharmaceutical company located in Parsippany, NJ. As the Senior Manager, you will be responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle.

Job Responsibilities:

• Serves as a liaison to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities.
• Interprets and communicates health authority correspondence effectively and quickly to senior leadership and clinical project teams.
• Partners with clinical project teams to assess regulatory support needs and aligns resources to provide regulatory support.
• Identifies and monitors regulatory issues and reports progress to management.
• Monitors regulatory submission activities and reviews regulatory documents prior to submission to ensure overall quality, compliance and timeliness.
• Assists in the planning, execution and assessment of product life cycle.
• Assists in planning and execution of major submissions and responses to regulatory authorities related to INDs, amendments, NDAs and supplements within company timelines and in accordance with regulations and guidelines.

Skills and Requirements:

• BS/BA in Life Sciences in a relevant field with 5 or more years of broad pharmaceutical experience, including 3 or more years of new drug regulated product strategy/submissions; or Master's Degree with 4 or more years of pharmaceutical experience and 2 or more years of related Regulatory experience.
• Working knowledge of relevant drug laws, regulations and guidance's/guidelines.
• Ability to contribute to the development and writing of a regulatory strategy document.
• Able to prioritize and work well in a fast-paced environment to multi-task, problem solve, and motivate and lead others.
• Able to present to senior leadership clearly, succinctly, with open-mindedness and willingness to defend difficult positions.
• Strong sensitivity for a multicultural and multinational environment.

If you are having difficulty in applying or if you have any questions, please contact Nick Walker at (+1) 646-367-2908 or n.walker@proclinical.com.

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.

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