What are the responsibilities and job description for the CMC Regulatory Scientist II - CMCREGSPEC 24-18410 position at NavitsPartners?
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
- 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.
- Supervisory experience and skills in metrics development.
- Experience with software such as Veeva Vault and ETQ.
- 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.
- 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.
- Preferred: Veeva Vault, ETQ
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.
