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Job Details
Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.
Purpose
- Lead and support CMC biologics activities for PharmaLex projects as part of a global team.
- Provide a broad range of regulatory affairs support..
- Proactively support clients to deliver quality reg CMC work.
Main tasks
Provide a wide range of flexible regulatory affairs services for different clients on a range of product types and therapeutic areas.Provide leadership and knowledge-based support for biologics CMC activities (e.G. compilation and review;gap analysis;CMC strategies;comparability exercises)
Provide project management for regulatory activitiesManage clients and other stakeholdersSupport business development;provide input into client proposals
Provide critical technical review of documentation based on established experienceProvide effective consulting support for CMC biologicsExperience and skills
Established experience in regulatory affairs activities including :Module 3 IND / IMPD authoring and reviewMAA / BLA gap analysisDevelopment of regulatory strategyScientific advice proceduresSubmission managementExperience with different territories, authorization procedures and health authoritiesExperience with development and life-cycle management productsExperience in biologics e.G. regulatory affairs, manufacturing, quality systems, process, analyticalEstablished experience with a wide range of biotech product types including : ATMPs, vaccines, recombinant proteins, plasma products and biosimilars.Focused and able to deliver high-quality work.Ability to work in a team.Strong sense of responsibility.Excellent written and verbal communication skills, with a particular focus on client-facing interactions.Educated to at least a relevant science degree level, preferably with a higher degree in a pharmaceutical discipline.At least seven years of experience in the biotech industry.What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time
Affiliated Companies
Affiliated Companies : PharmaLex Spain S.L.U.