Sr scientist, regulatory affairs (cmc) – Campinas/SP

Responsabilidades

• The incumbent will be accountable for implementing regional CMC strategy for international markets for post-approval CMC supplements and new product submissions with a focus on achieving right-first-time submissions, including the following activities:
• For assigned product portfolio, develop robust CMC regional regulatory strategies for new marketing applications, Scientific Advice and post-approval changes, as appropriate.
• Working collaboratively with Global CMC RA Product Leads, the team will ensure right first-time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the product lifecycle.
• Ensure that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Franchise portfolio, commercial and operational strategies and issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.
• Support Organon Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions (as CMC content subject matter expert).
• Act as Regulatory CMC SME in regional post approval requirements, ensure awareness of regional regulatory policy trends and maintain/update the regulatory intelligence repository for regional markets, including communicating proactively with Global CMC Product Leads on regional registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to support right first-time submissions.
• Ensure high quality and timely responses to Regulatory Agency questions in regional markets and fulfillment of regulatory commitments to Regulatory Agency deadlines.
• Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.
• Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.
• Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business.

Requisitos

• The candidate must possess a Bachelor’s or Master’s Degree in chemistry, pharmacy, biology or a related science, with a minimum of 4 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory.
• The ideal candidate will have experience in Regulatory Affairs for the regional markets, with a focus on Regulatory CMC requirements for small molecule/biologic/biosimilar products, development, manufacturing and/or quality assurance. Direct Health Authority experience would be an advantage.
• He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.

Marcado como: Assuntos Regulatórios, Indústria Farmacêutica, Insumos Farmacêuticos, Pesquisa e Desenvolvimento, Produtos Farmacêuticos