Regulatory Affairs, CMC Manager

  •  

Princeton, NJ

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 34 days ago

  by    Michelle Manzon

Job Summary

Title: Regulatory Affairs, CMC Manager

Company: Pharmaceutical Company

Location: Princeton, New Jersey

Type: Permanent Role

Notes: No Corp to Corp

Responsibilities:

· Prepare/coordinate/file/manage the nonclinical, clinical and CMC content of IND/CTAs, NDA, annual reports, and information amendments in multiple countries.

· Lead the preparation and filing of the regulatory applications (IND/CTA, NDA/BLA/MAA).

· Lead the preparation of responses to questions from Regulatory Authorities.

· Interface with functional areas to identify and obtain information required for regulatory submissions.

· Develop and/or review regulatory documents to ensure that all submissions are of high quality.

· Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met.

· Participate in the development of regulatory strategies and provide strategic input and regulatory advice to the project teams on development programs.

· Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks.

· Interface with global regulatory authorities and consultants as needed.

· Support the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages.

· Provide critical review of documents (SOPs, protocols, and reports) related to manufacturing, as necessary.

· Review and provide regulatory assessment to proposed CMC changes.

· Maintain knowledge of current global rules, regulations, and guidance governing development of drugs and biologics in all phases of development.


Requirements:

· The successful candidate must possess a Bachelor's degree in Pharmacy, Biology, Chemistry or related healthcare functional area

· Regulatory Affairs Certification is preferred

· Strong scientific background with at least five (5) years of experience in CMC Regulatory Affairs in the biotechnology or pharmaceutical industries.

· Thorough understanding of global drug/biologics manufacturing regulations and guidelines.

· Excellent CMC technical writing and communications skills with strong background in small/biological molecule pharmaceutical development, manufacturing, and regulatory writing

· Experience in addressing CMC-related regulatory queries from global health authorities

· Proven ability to successfully manage major submissions and critical projects to deadlines.

· Proven ability to successfully interact with regulatory authorities.

· Excellent attention to detail, and strong computer and organizational skills required

· Strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills

· Prior experience with parenteral, extended release products and biologics is desirable.

Contacts: APPLY TODAY and one of our recruiters will reach out to you shortly.

Referral Bonus: As always, we will give you a referral bonus if we place someone you refer over to us! Ask for details.

Salary

$90K - $110K