CMC Regulatory Scientist II - CMCREGSPEC 24-18410

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.