CMC Regulatory Scientist II

Title: CMC Regulatory Scientist II/Associate Principal Scientist, Regulatory Affairs​

Duration: 12 months

Location: Rahway, NJ

Job Description:

• The Associate Principal Scientist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance.
• The Associate Principal Scientist is also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products.

Responsibilities:

60% to 80%:

• Work independently and effectively to manage and author regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations.
• Review technical reports and scientific information provided to support regulatory submissions
• Identify potential risks and propose mitigation strategies; communicate potential regulatory issues to management, as needed.
• Critically evaluate health authority questions with the respective CORA and lead the answer team of cross-functional
• SMEs to compile the responses in order to author and submit the responses timely to meet health authority deadlines
• Actively participate on new product development teams as well as other project teams and initiatives and deliver on all assigned regulatory milestones.

10% to 20%:

• Change Management Regulatory Impact Assessment: Provide regulatory assessments for post approval change proposals, filing strategies and timelines
• Renewals and Geo-Expansions: Support license renewals and geo-expansion activities by supporting CORA requests for dossiers and GMP documentation
• Maintain regulatory information in accordance with processes and procedures to support regulatory compliance
• Continuously build and share knowledge of CMC-related global regulations and guidelines, authority expectations, as well as current industry standard, while also helping to coach others in a collaborative manner, using good communication

Education

• Ph.D. with > 4 years, M.S. with > 7 years, or B.S with > 10 years relevant industry experience in related R&D sciences
• discipline (engineering, chemistry, biological sciences, pharmacy, veterinary, regulatory)

Skills Required:

• Required: minimum of 2 years authoring CMC sections for regulatory submissions.
• Preferred: experience and skills in a supervisory role and metrics development.
• Hands on experience in R&D pharmaceutical development (formulations- development pharmaceutics, process technology, analytical method development and validation, and/or packaging development)
• Experience authoring technical reports and regulatory submissions, experience reviewing scientific information, with sound judgement and attention to detail
• Demonstrated understanding of cross-functional relationships across the business (manufacturing, packaging, quality control and assurance as well market demands and supply chain)
• Strong Leadership skills (problem-solver), communication and interpersonal skills with high level of professionalism to collaborate with internal partners and to liaise with regulatory authorities (CVM/FDA, EMA)
• Proficient in English, both written and oral
• Ability to manage multiple projects and products, with high level of organizational skills for prioritization planning, and with flexibility and technical acumen to shift roles on short notice.

Software:

• Experience with Veeva Vault is nice to have
• Experience with ETQ is nice to have

Notes:

• 1 Year assignment with a possibility of extension.
• Hybrid - 3days onsite(Tues and Wed is must)