Associate Director, CMC Regulatory

Required Skills, Experience, and Education

• BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.

• 10+ years of pharmaceutical / biotech drug development experience with 5 + years of experience of global CMC regulatory affairs.

• Experience in CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM).

• Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.

• Working experience and content knowledge in CMC development of NCEs (small molecules) or equivalent.

• Demonstrated experience in effective collaboration with internal and external stakeholders.

• Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment.

• Ability to operate effectively in a fast-paced, matrixed, global environment.

• Effective written and verbal communication skills and excellent interpersonal skills.

1. 1

   Develop, lead, and implement global CMC regulatory strategies to support the clinical development, registration, and post-marketing activities.

2. 2

   Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.

3. 3

   Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the development of the investigational product(s) and marketed products and ensure applicable regulatory requirements are appropriately met.

4. 4

   Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify regional/country-specific CMC requirements to support global applications, and to drive the CMC submission timelines in order to meet business objectives.

5. 5

   Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.

6. 6

   Lead and/or contribute to internal process improvements, SOP development, and organizational initiatives to support globalization of RevMed’s products.Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders.