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Senior Regulatory Affairs Associate or Consultant - CMC Biologics

Parexel International Corporation

USA - Any Region - Home Based

Excellent opportunity for an experienced CMC Biologics Regulatory Affairs professional to bring your talent, excellent communication skills, strong regulatory writing experience, and CMC expertise to Parexel Consulting as a Senior Regulatory Affairs Associate / Consultant! This is tremendous opportunity to gain exposure to novel technologies and gain tremendous exposure from clinical trials to post approval, to maintenance, and everything in between!

In this highly visible as a Senior Regulatory Affairs Associate / Consultant role, you will partner closely with a large multinational pharmaceutical company and support the regulatory submission activities for the commercial and development global product licenses and applications.

Responsibilities: Author regulatory CMC documents to include Module 3 components Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders Ad hoc RACMC support to line manager Assist with post-approval and investigational life cycle management as needed, including but not limited to post approval supplements and variations, annual reports, and investigational (IND/IMPD) amendments, per team and program timelines QualificationsNECESSARY SKILLS Experience in regulatory submissions roles, supporting the compilation of module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents Good writing skills for technical writing Detail oriented and highly organized Good verbal communication skills for leading meetings and remote interactions Work well in team setting on a fast-paced business critical project Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company EDUCATION AND EXPERIENCE Biologic investigational product experience is required Scientific and educational background (Bsc or MSc) to understand pharmaceutical drug development concepts, regulatory concepts and create documentation based on these concepts Comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance Excellent project management skills Previous relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity with at least 1-2 years of relevant experience for a Senior Regulatory Affairs Associate. At least 3+ years of experience relevant experience for a Regulatory Affairs Consultant This role may require <15% travel to client location in the future as needed

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2022-06-29

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