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Regional Technical Regulatory Coordinator (CMC) – Latin America - Brazil  

Company managed [?] Still accepting applications

Posted on : 03 May 2017

Project Description

Regional Technical Regulatory Coordinator (CMC) – Latin America-REG002896

Descrição:
Role Description

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.

Responsibilities:

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:

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Coordination of regulatory change assessments from local countries within the region and documentation within CMC change management electronic systems.

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Prioritization of execution of submissions as per global regulatory strategy and in coordination with local affiliates to ensure regulatory conformance.

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Seeking opportunities to maximize submission efficiency and quality to ensure a high rate of submission approvals by Health Authorities.

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Tracking of submission and approvals, and ensuring bidirectional communication of status with local and global CMC teams.

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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.

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Ensuring submissions are prepared in alignment with Health Authority commitments as result of license/dossier approval.

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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.

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Ensuring awareness of regional regulatory policy trends and maintaining the regulatory intelligence repository for regional markets under responsibility.

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The candidate may be required to travel to other MSD sites on a periodic basis.

Qualificações:
Qualifications

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The candidate must possess a degree in science with experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory;

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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;

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He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks;

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Must have fluent English and Spanish (proven ability to communicate effectively in both a written and verbal format);

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Ability to influence and work both independently and collaboratively in a team structure;

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Proven ability to work well under pressure.

Cargo
: 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