Regional Technical Regulatory Coordinator (CMC) – Latin America - Brazil
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The Regional Technical Regulatory Coordinator will be responsible for development of regional CMC strategy, preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registration for all MSD products, serving as a link between local Affiliate Drug Regulatory Affairs (DRA) team requirements and global CMC strategy to ensure right at first-time submissions to Health Authorities.
The Regulatory CMC Regional Hub is a key component of MSD´s strategy to build regional regulatory knowledge, effective local relationships with MSD country offices in order to deliver appropriate regulatory strategies and right first-time regulatory submissions and support conformance of MSD´s manufacturing practices with registered details.
The incumbent will be accountable for 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:
Coordination of regulatory change assessments from local countries within the region and documentation within CMC change management electronic systems.
Prioritization of execution of submissions as per global regulatory strategy and in coordination with local affiliates to ensure regulatory conformance.
Seeking opportunities to maximize submission efficiency and quality to ensure a high rate of submission approvals by Health Authorities.
Tracking of submission and approvals, and ensuring bidirectional communication of status with local and global CMC teams.
Preparation of submission documentation by modification and consolidation of global documentation for local submission according to local/regional requirements, and in consultation with subject matter experts in global CMC and local countries. Preparation of timely responses to Health Authority questions resulting from post-approval or new product submissions in regional markets under responsibility.
Ensuring submissions are prepared in alignment with Health Authority commitments as result of license/dossier approval.
Representing regional CMC strategy on cross-functional teams to ensure mutual understanding of local/regional CMC requirements and program complexities, and maintaining close communication with regional and local Affiliates DRAs, regional Supply Chain teams, global CMC product leads and the Regulatory network.
Ensuring awareness of regional regulatory policy trends and maintaining the regulatory intelligence repository for regional markets under responsibility.
The candidate may be required to travel to other MSD sites on a periodic basis.
The candidate must possess a degree in science with 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, ideally with a focus on Regulatory CMC requirements for small molecule/biologic products of human use, development, manufacturing and/or quality assurance;
He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks;
Must have fluent English and Spanish (proven ability to communicate effectively in both a written and verbal format);
Ability to influence and work both independently and collaboratively in a team structure;
Proven ability to work well under pressure.
: Regulatory Affairs - CMC Job Title:Sr. Spclst, Regulatory Affairs-CMC
Local principal: LATAM-Brasil-SP-São Paulo
Status do funcionário: Regular
Número de vagas: 1
Company Trade Name:MSD