Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Rahway, NJ 07065
About the Job
Responsibilities:
- 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.
- 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 Product 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.
- 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.
- 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).
- Required: minimum of 2 years authoring CMC sections for regulatory submissions.
- 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.
- Experience with Veeva Vault is nice to have.
- Experience with ETQ is nice to have.
- 1 Year assignment with a possibility of extension.
- Hybrid - 3days onsite(Tues and Wed is must).
Source : Katalyst Healthcares & Life Sciences