新泽西地区招聘生物药Regulatory Affairs Director/AD

吴红岩医药荐客 2022-01-04

POSITION DESCRIPTION

TITLE: Director/AD, CMC Biologics Regulatory Affairs

DEPARTMENT: Global Regulatory Affairs

SUPERVISOR: VP, Head of Global Regulatory Affairs

POSITION SUMMARY:

This new position is located at Princeton, NJ. The responsibilities include working closely with functional areas and project teams to support regulatory chemistry and manufacturing control (CMC) execution as it pertains to the biosimilar/biologics programs that Global Regulatory Affairs supports. The basic role is to provide CMC biologics and regulatory guidance to the project teams, lead the development and implementation of global CMC regulatory strategy for biosimilar/biologics, provide CMC regulatory support for the new and ongoing clinical trials, prepare the CMC part of the IND/BLA filing and response to HA questions related quality, and support all CMC biologics regulatory activities. The individual must possess a thorough knowledge of global regulation and guidance governing biosimilar/biologics in all phases of development. Strong communication and management skills are required.

RESPONSIBILIITES:

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

· Lead the preparation and filing of the regulatory applications (IND/IMPD, 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.

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

CANDIDATE REQUIREMENTS:

· MS, or PhD in relevant technical discipline

· Strong scientific background with at least eight (8) years of experience in CMC biologics Regulatory Affairs in the biotechnology or pharmaceutical industries.

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

· Excellent CMC technical writing and communications skills with strong background in biosimilar/biologics 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

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