# CMC Regulatory Affairs Specialist

**Company**: GSK
**Location**: Belgium-Wavre
**Experience**: senior
**Job type**: full-time
**Salary**: PLN 236,250 to PLN 393,750 (Poland), EUR 48,225 to EUR 80,375 (Italy), EUR 69,750 to EUR 116,250 (Belgium)
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Belgium-Wavre/Regulatory-Manager--Strategy---CMC-RA-Vaccines-Development-Projects_449814?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_a5011566-aab

## Description

We are seeking a CMC Regulatory Affairs Specialist to be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.

**Responsibilities:**

- Be responsible for the global CMC regulatory activities for assigned projects and respond readily to changing events and priorities.

- Develop CMC strategy for CMC submission documents from early phase clinical submissions to marketing applications.

- Interpret and advise teams on regulations, guidelines, procedures, and policies relating to development, registration, and manufacture of medicinal products.

- Ensure all appropriate CMC regulatory aspects for clinical trials/product release are in place.

- Work in cross-functional matrix project teams to define proper regulatory CMC filing strategy.

- Maintain high-quality standards and seek to raise levels of performance through continuous improvement.

- Ensure regulatory compliance is maintained and share best practices within the CMC Regulatory teams.

- Engage in CMC Subject Matter Expert activities internally.

**Requirements:**

- BSc Life sciences or related scientific discipline (or PhD).

- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience.

- Sound knowledge of drug development, manufacturing processes, and supply chain.

- Knowledge of worldwide CMC regulatory requirements.

- Good time management skills with the ability to effectively plan, prioritize, and coordinate multiple tasks.

- Strong interpersonal, presentation, and communication skills.

**What We Offer:**

- Competitive salary: PLN 236,250 to PLN 393,750 (Poland), EUR 48,225 to EUR 80,375 (Italy), EUR 69,750 to EUR 116,250 (Belgium).

- Annual bonus and eligibility to participate in our share-based long-term incentive program.

**Why GSK?**

- We are a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together.

## Skills

### Required
- Communication
- Influencing Without Authority
- Learning Agility
- Pharmaceutical Regulatory Compliance
- Problem Solving
- Regulatory Strategies
- Strategic Leadership

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Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/Belgium-Wavre/Regulatory-Manager--Strategy---CMC-RA-Vaccines-Development-Projects_449814?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)