Title: Regulatory Affairs, CMC Manager
Company: Pharmaceutical Company
Location: Princeton, New Jersey
Type: Permanent Role
Notes: No Corp to Corp
· 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.
· 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.
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