Title: CMC Regulatory Specialist (Associate Principal Scientist)
Location: Rahway, NJ 07065
Duration: 12 Months (possibility of extension)
Work Schedule: Hybrid – 3 days onsite (Tuesday and Wednesday required)
Education Requirements:
Ph.D. with >4 years of relevant industry experience
M.S. with >7 years of relevant industry experience
B.S. with >10 years of relevant industry experience
Fields of Study: Engineering, Chemistry, Biological Sciences, Pharmacy, Veterinary, or Regulatory
Skills & Competencies Required:
Essential:
Minimum 2 years of experience authoring CMC sections for regulatory submissions.
Hands-on experience in R&D pharmaceutical development (e.g., formulations, process technology, analytical methods, packaging development).
Experience authoring technical reports, reviewing scientific information, and regulatory submissions.
Strong understanding of cross-functional relationships (e.g., manufacturing, packaging, quality assurance, and supply chain).
Leadership skills with problem-solving ability, attention to detail, and sound judgment.
Excellent written and oral communication in English.
Ability to manage multiple projects with strong organizational and prioritization skills.
Preferred:
Supervisory experience and skills in metrics development.
Experience with software such as Veeva Vault and ETQ.
Responsibilities:
Regulatory Submission Strategy & Preparation (60%-80%):
Develop CMC regulatory submission strategies and timelines for pharmaceutical projects/products.
Independently manage and author regulatory CMC dossiers, annual reports, variations, and responses to authority inquiries.
Review and evaluate technical reports and scientific data supporting regulatory submissions.
Identify risks, propose mitigation strategies, and communicate potential regulatory issues to management.
Lead cross-functional teams to compile and submit responses to health authority questions.
Participate in new product development teams and deliver on all assigned regulatory milestones.
Change Management & Compliance (10%-20%):
Provide regulatory impact assessments for post-approval changes and develop filing strategies.
Support license renewals and geo-expansion activities by providing necessary documentation.
Maintain regulatory information in compliance with established procedures and standards.
Build and share knowledge of global CMC regulations, guidelines, and industry standards while mentoring team members.
Software Experience:
Preferred: Veeva Vault, ETQ
Additional Notes:
This role requires a professional who can adapt quickly, work collaboratively, and deliver high-quality regulatory documentation in a fast-paced environment. Applicants must possess a deep understanding of global regulatory standards and a proven ability to liaise effectively with regulatory authorities.