Summary of Job:
The Senior Director, CMC Regulatory Affairs, will be responsible for providing tactical and strategic regulatory support for marketed products and development programs. As part of his/her responsibilities, the Senior Director will collaborate with key functional areas (including Technical Operations and Quality) to prepare high quality, timely and effective regulatory submissions in support of an approved NDA and MA and their corresponding IND/CTAs. In addition, he/she will coordinate and participate in regulatory agency interactions, as needed, including with the US FDA and various health agencies outside of the US. In this position, the Senior Director will also support, either directly or in alliance with Nalpropion’s partners/distributors, the submission of marketing applications to countries in greater Europe (non-EU), the Middle East, Africa, Asia, Mexico/South America and the Pacific. As part of his/her responsibilities, the Senior Director will ensure that all assigned regulatory projects are prepared in adherence with US and any other relevant Health Authority regulations, procedures and guidelines.
Essential Duties and Responsibilities:
- Develop and effectively communicate US and global drug development and product lifecycle strategies across regions and programs with a regulatory CMC perspective.
- Manage all CMC aspects of new and existing regulatory applications, including INDs, CTAs, NDAs, Marketing Authorizations and Drug Master Files.
- Author and/or critically review CMC submission documents to support high-quality NDA supplements, MA variations, IND amendments, CTAs, annual reports and DMFs.
- Interface with regulatory agencies as needed, including routine communications, meeting requests, and preparation of supporting documentation.
- Support business development activities related to partnering/distributorship and licensing opportunities including acting as a regulatory resource for due diligence assessments of in-licensing opportunities.
- Represent Regulatory Affairs at various project teams and working group meetings, particularly as it relates to CMC regulatory requirements, procedures and activities for the US, Europe and rest-of-world regions.
- Monitor emerging regulatory trends and precedents and assess and communicate their potential impact on development programs and ongoing lifecycle plans.
- Manage external regulatory and development vendor resources, as needed.
- Ensure that all CMC activities are conducted in compliance with applicable regulations and guidelines.
- Manage CMC Regulatory Affairs Department staff and contractors.
- Ensure adherence to Regulatory Affairsbudget and achieving company regulatory goals according to agreed timelines and with a high level of quality.
- Coordinate and ensure submissions are prepared and completed to project plans, timelines and budget.
- Provide regulatory assessment on GMP requirements and questions
- Review and draft SOPs, as needed.
- Bachelor’s Degree in chemistry, biochemistry or other scientific discipline (advanced degree or relevant certification a plus).
- Knowledge and skills acquired typically through a minimum of 8 years’ relevant industry experience in CMC Regulatory Affairs.
- Technical knowledge of and experience with US and European regulations; regulatory knowledge and experience in other regions is a plus.
- Experience working effectively in cross- functional teams with other internal and external stakeholders and communicating on behalf of regulatory affairs.
- Ability to integrate scientific and regulatory considerations in developing and implementing regulatory strategies.
Other Skills and Abilities:
- Excellent oral and written communication skills, self-motivated, good team player, willingness to travel as needed.
- Strong knowledge of GMP.
- Ability to coordinate regulatory submissions with minimal supervision.
- Proficient computer and word processing skills.
- Strong attention to detail and organization skills.
- Flexible and adaptable in changing environments.