Global Oncology Regulatory Affairs – Associate Director

Merck; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co., Inc. in Rahway, NJ, is seeking Associate Director, Regulatory Affairs to lead global regulatory strategy for Oncology products, collaborating with global leads to prepare submissions and maintain lifecycle.

The role requires extensive experience in drug development, interaction with major agencies, and strong communication and analytical skills; hybrid work, competitive benefits, and potential bonus and long-term incentives.

Qualifications

• Bachelor’s Degree with at least 5 years of relevant experience in the pharmaceutical industry.
• Master’s Degree with at least 2 years of relevant experience in pharmaceutical industry.
• MD/PhD or other related doctoral degree in biological science, chemistry or related discipline with relevant experience.

Responsibilities

• Assisting in Regulatory Agency communications and submissions, including marketing applications, INDs, pediatric plans and reports; track, author, shepherd and review responses.
• Implementing strategy to develop Agency background packages and documents for submissions.
• Communicating with Agencies and attending Agency meetings to assist the global regulatory lead.
• Participating as an active member on the global regulatory team and attend cross-functional meetings.
• Conducting research on guidelines and competitive intelligence to facilitate regulatory strategy; assist in authoring strategy documents.
• Collaborating with Regulatory Operations, Clinical Safety, Labeling, CMC and other functions on regulatory strategy.
• Support maintenance of oncology programs (quality compliance and lifecycle management).
• Support of global regulatory lead in label development.
• Assisting with process improvement initiatives.
• Performing regulatory administrative activities.

Skills

Global Regulatory

Regulatory Submissions

Regulatory Strategy

Regulatory Communications

Regulatory Documents

Regulatory Experience

Investigational New Drug

Label Development

Life Cycle Planning

Pharmaceutical Industry

Product Registrations

Regulatory Filings

Regulatory Reporting

Regulatory Strategies

Regulatory Projects

Cross-Functional Teamwork

Communication Skills

Analytical Skills

Global Collaboration

Regulatory Science

Project Management

Stakeholder Engagement

Education

Bachelor’s Degree

Master’s Degree

MD/PhD or related doctoral degree

Job description

Merck & Co., Inc. in Rahway, NJ, is seeking Associate Director, Regulatory Affairs to lead global regulatory strategy for Oncology products, collaborating with global leads to prepare submissions and maintain lifecycle.

The role requires extensive experience in drug development, interaction with major agencies, and strong communication and analytical skills; hybrid work, competitive benefits, and potential bonus and long-term incentives.