Associate Principal Scientist, Regulatory Affairs Seeking R&D background experience along with the Regulatory Affairs background
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. Competencies Required:
- 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)
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. MAJOR ACTIVITIES AND 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
