Job Description

The Position

Purpose

This position will be responsible for the execution and management of life-cycle submissions for all Roche products as well as new product registrations by focusing on the local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right-first-time submissions to Health Authorities.

Key Responsibilities

The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR Product Teams(Squads).

In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in international markets associated with management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality, and rate of submission approvals by Health Authorities.

Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

Assemble lifecycle submissions for markets under responsibility to guarantee right-first-time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

Act as subject matter expert in regulatory requirements for post-approval submissions and maintain the regulatory intelligence repository for regional markets under the responsibility.

Ensure timely update of the CMC changes management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under the responsibility.

Manage tracking of commitments with a Health Authority as a result of license/dossier approval and ensure commitments due dates are met.

Qualifications

The candidate must possess a degree in science (advance degree preferred) with 3 - 8 years of experience in the pharmaceutical industry.

The ideal candidate is to have strong experience in the Regulatory Affairs for the International markets, CMC requirements for small molecule/biologic products, development, manufacturing, and/or quality assurance experience.

He/she to demonstrate effective problem solving, strong understanding of regulatory strategies, excellent interpersonal skills, detail-oriented, and the ability to prioritize multiple tasks.

Must have a proven ability to communicate effectively in both a written and verbal format. The ideal candidate will be fluent in 1-2 languages spoken in the region of responsibility, in addition to English.

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

Proven ability to work well under pressure.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.

Roche