CMC Regulatory Affairs Scientist

Job Title: CMC Regulatory Affairs Scientist
Location: Hybrid, Rahway, New Jersey 07065
Duration: 12 Months

Notes: Hybrid role with 3 days onsite (Tuesdays and Wednesdays are mandatory)

Qualifications:
• Education: Ph.D. with 4 years, M.S. with 7 years, or B.S. with 10 years of relevant industry experience in R&D sciences (engineering, chemistry, biological sciences, pharmacy, veterinary, regulatory).
• Skills: Minimum 2 years of authoring CMC sections for regulatory submissions. Supervisory experience and metrics development preferred.
• Competencies: Hands-on R&D pharmaceutical development, technical report authoring, regulatory submissions, cross-functional business understanding, strong leadership, communication, and interpersonal skills.
• Software: Experience with Veeva Vault and ETQ is a plus.

Responsibilities:
• Develop CMC regulatory submission strategies and timelines.
• Prepare and review regulatory CMC dossiers for new and existing products.
• Manage and author regulatory CMC dossiers, renewals, variations, and responses to authority questions.
• Evaluate health authority questions and lead cross-functional teams to compile responses.
• Participate in new product development teams and deliver on regulatory milestones.
• Provide regulatory assessments for post-approval changes and support license renewals and geo-expansion activities.
• Maintain regulatory information and ensure compliance with global regulations and guidelines.