Associate Principal Scientist
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.
Primary Responsibilities and Activities:
- 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.
- Provide regulatory assessments for post approval change proposals, filing strategies and timelines
- 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.
- 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 and interpersonal skills
- Performs other tasks as requested by management.
Qualifications:
Required Experience and Skills:
- Hands on experience in R&D pharmaceutical development (formulations- development pharmaceutics, process technology, analytical method development and validation, 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
Preferred Experience and Skills:
- Supervisory experience
- Managerial skills- Six Sigma metrics development
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) and at least 2 years authoring CMC sections for regulatory submissions.
Work arrangements:
This position currently a hybrid work model with 3 days reporting on site in Rahway, NJ.