Associate Director, Regulatory Liaison - Oncology
Merck
9 days ago
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Primary Responsibilities
- Assist with regulatory agency communications and submissions (marketing applications, INDs, pediatric plans, annual/periodic reports), including tracking, authoring, shepherding, and/or reviewing responses to agency requests.
- Implement strategy to develop agency background packages and documents for marketing submissions.
- Communicate with agencies and attend agency meetings as needed.
- Participate on the global regulatory team; attend cross-functional meetings with and to support the global regulatory lead.
- Research and review guidelines, regulatory precedence, and competitive intelligence to facilitate regulatory strategy; assist in authoring regulatory strategy documents.
- Collaborate and communicate regulatory strategy with Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC), and other functional areas.
- Support maintenance (quality compliance and life cycle management) of oncology programs.
- Support label development (with global regulatory lead).
- Assist with process improvement; perform regulatory administrative activities as needed.
Education Minimum Requirements
- M.D. or Ph.D. (or related doctoral degree in biological science/chemistry or related discipline).
- Master’s degree with at least 2 years relevant pharmaceutical industry experience; or
- Bachelor’s degree with at least 5 years relevant pharmaceutical industry experience.
Required Experience and Skills
- Drug development experience.
- Prior regulatory experience interacting with a major regulatory agency.
- Excellent oral/written communication; strong organizational skills; flexibility.
- Strong scientific and analytical skills with attention to detail.
Preferred Experience/Skills
- Oncology product experience.
Required/Key Skills
- Drug development, protocol review, regulatory strategy development, regulatory submissions/communications/compliance, regulatory affairs management, facilitated communication, scientific research, strategic thinking.
Application Instructions
- Current employees: apply via internal link; applicants: apply through the posted application link (deadline as stated on posting).
- Assist with regulatory agency communications and submissions (marketing applications, INDs, pediatric plans, annual/periodic reports), including tracking, authoring, shepherding, and/or reviewing responses to agency requests.
- Implement strategy to develop agency background packages and documents for marketing submissions.
- Communicate with agencies and attend agency meetings as needed.
- Participate on the global regulatory team; attend cross-functional meetings with and to support the global regulatory lead.
- Research and review guidelines, regulatory precedence, and competitive intelligence to facilitate regulatory strategy; assist in authoring regulatory strategy documents.
- Collaborate and communicate regulatory strategy with Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC), and other functional areas.
- Support maintenance (quality compliance and life cycle management) of oncology programs.
- Support label development (with global regulatory lead).
- Assist with process improvement; perform regulatory administrative activities as needed.
Education Minimum Requirements
- M.D. or Ph.D. (or related doctoral degree in biological science/chemistry or related discipline).
- Master’s degree with at least 2 years relevant pharmaceutical industry experience; or
- Bachelor’s degree with at least 5 years relevant pharmaceutical industry experience.
Required Experience and Skills
- Drug development experience.
- Prior regulatory experience interacting with a major regulatory agency.
- Excellent oral/written communication; strong organizational skills; flexibility.
- Strong scientific and analytical skills with attention to detail.
Preferred Experience/Skills
- Oncology product experience.
Required/Key Skills
- Drug development, protocol review, regulatory strategy development, regulatory submissions/communications/compliance, regulatory affairs management, facilitated communication, scientific research, strategic thinking.
Application Instructions
- Current employees: apply via internal link; applicants: apply through the posted application link (deadline as stated on posting).