5 months ago
Director/Senior Director Regulatory Affairs - CMC Small Molecule
Hybrid: 3 days a week in office
Location: Chester County, PA
- Lead and support the CMC aspects of regulatory planning and execution for my client's early to late development assets working with the cross-functional development and CMC teams.
- Coordinating, authoring/preparing and reviewing CMC sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments to ensure applicable regulatory requirements are met.
- Directing development of responses to all regulatory issues/queries involving CMC aspects of the development programs to achieve timely resolution.
- Understanding, interpreting and advising teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products to assess risk/impact on business and development program/s.
- Assessing data with technical functional expertise to solve problems and make good decisions for the overall business.
- Building partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
- Coordinating, authoring/preparing and reviewing documents to ensure timely filing of CMC regulatory submissions (including INDs/CTAs, NDAs/MAAs, amendments/variations, safety reports, annual updates and briefing documents).
- Guiding CMC stakeholders on regulatory issues and conducting impact assessment for manufacturing changes; maintaining records of the decisions per existing or new process to achieve compliance.
- BA/BS degree is required, Advanced degree preferred
- Minimum of 5-8 years of experience in CMC Regulatory Affairs or related experience in positions of increasing responsibility, preferable in pre-marketing and post-marketing
- Extensive regulatory experience including IND/CTA, NDA/MAA, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing complex regulatory CMC strategies with a proven track record of significant regulatory accomplishments. Experience preferred.
- Experienced in Regulatory Agency meetings resulting in successful outcomes.
- Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP and CTD/eCTD, and US FDA CDER requirements for the drug approval process.
- Previous participation in preparing Regulatory submissions (e.g., IND, CTA, NDA, etc.)
- Solid understanding of the eCTD specifications for electronic submissions.