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Ra-Cmc Specialist
hace 3 meses
DescriptionWe are looking for an expert in Regulatory Affairs for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (Rx or non-monograph OTC drugs).This person will contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities.Key ResponsibilitiesContribute to global regulatory CMC strategies.Assess regulatory impact of proposed CMC changes and contribute to the CMC regulatory strategies that support change implementation.Reviews data provided to support dossier preparation; identify gaps and risksand work with stakeholders to solve them.Writes / assembles CMC sections of regulatory submissions.Develop and maintain project plans and schedules for CMC submissions.Ensures all CMC dossiers are stored in the company database.Provide guidance minimally on ICH, FDA and EU CMC guidelines.Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory goals.Share knowledge and experience with other team members.Collaborate with service providers contracted to support a project, if appropriate.Skills & QualificationsEffective experience in CMC Regulatory Affairs.Background in pharmaceutical industry.Experience with topical and/or systemic drugs (Biologics and/or Small Molecules).What we offer in returnYou will be working for an organization that embraces diversity & inclusion and believes we will deliver better outcomes by reflecting the perspectives of our diverse customer base.You will receive a competitive compensation package with bonus structure and extended benefit package.You will be able to work in a hybrid work culture.You will participate in feedback loops, during which a personalized career path will be established.You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.#J-18808-Ljbffr
