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Regulatory Affairs CMC Associate
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Regulatory Affairs CMC Associate
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Associate Director, Regulatory Affairs Cmc
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ALX Oncology Inc. South San Francisco, United StatesWe are looking for an** Associate Director/Director, Regulatory Affairs CMC **to join our team. · **Responsibilities**: · These include but are not limited to: · - Providing dynamic regulatory leadership to project teams and working collaboratively with cross-functional team memb ...
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Sr. Manager/Associate Director, CMC Development
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Abbvie South San Francisco, United States Full timeCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
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AbbVie, Inc South San Francisco, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
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BioSpace South San Francisco, United StatesJob Details · Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key the ...
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AbbVie South San Francisco, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
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AbbVie South San Francisco, United StatesJob Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...
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Associate Director, Drug Substance Manufacturing
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AbbVie South San Francisco, United States Full time· Company Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic ar ...
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Senior Associate Scientist
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Gilead Sciences, Inc. Foster City, United States Full timeDescription · Key Responsibilities · Senior Associate, Global External Manufacturing, Small Molecule Drug Substance (DS) works to support uninterrupted supply of Gilead's clinical and commercial products through execution of manufacturing campaigns within our global external co ...
Regulatory Affairs CMC Associate - San Mateo, United States - Fladger Assoc. Inc.
Description
Job DescriptionJob Description
Foster City, CA
Contract Duration: 6-18 months
Rate:
Negotiable
Responsibilities:
Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY
Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology, HIV and liver disease.
The Associate, working with the project team and regional regulatory leads in the US, EU and other countries, will support documentation for submission to regulatory authorities.
May serve as regional lead on cross-functional/ cross-regional Regulatory Submission Teams.May participate on other Subteams, as applicable.
Responsible for preparing and submitting regulatory documents which require interaction with departments in and outside of Regulatory Affairs CMC for investigational and commercial biologics and small molecule products, in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Examples include original INDs, NDAs, BLAs, amendments, supplements, annual reports and license renewals.Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs and work instructions.
Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory Department.
Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling and for ensuring product packaging and associated information is updated and maintained in accordance with the product license as applicable.
Maintains knowledge of regulatory requirements and communicates changes in regulatory information to line manager and regulatory project teams in a timely manner.
Work cooperatively with regional regulatory sites to support the accurate and timely communication of critical information.Provide support for cGMP activities as they relate to Regulatory Affairs CMC`.
Work is performed cross-functionally within a matrixed organization under supervision of senior Regulatory Affairs CMC professionals and line manager.
Experience:
BS/BA Degree in Scientific field preferred and 2 years of relevant
Pharmaceutical/Biotech
industry experience, for example in Regulatory Affairs CMC.
Excellent organizational skills and ability to work on multiple projects with tight timelines is required.
Excellent verbal and written communication skills and interpersonal skills are expected.
Must work well under demanding deadlines and have excellent attention to detail.
Must have a reasonable understanding of regulatory requirements, including ICH requirements and US regional requirements
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