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.