Assignment Description:
We are looking for a Senior Regulatory CMC Manager to join our dynamic team.
What you will work on:
- Manage and oversee regulatory CMC submissions for both new and existing products, ensuring compliance with national and international regulatory requirements.
- Provide strategic regulatory guidance on CMC activities throughout the product lifecycle, from development to post-market.
- Prepare and review high-quality CMC documentation for regulatory submissions (CTAs, MAAs, variations, etc.) and ensure timely delivery.
- Collaborate closely with cross-functional teams, including R&D, manufacturing, and quality assurance, to ensure alignment of regulatory strategies with business objectives.
- Serve as a regulatory liaison with health authorities, ensuring clear and effective communication during regulatory interactions.
- Monitor changes in CMC-related regulatory guidelines and standards and assess their impact on the company’s products and processes.
- Support internal teams in responding to regulatory authority questions and managing product-related risks.
What you bring:
- A university degree in a relevant field (e.g., chemistry, pharmacy, pharmaceutical sciences) or extensive experience in Regulatory CMC.
- At least 2-3 years of experience working within CMC Regulatory Affairs.
- Comprehensive knowledge of regulatory frameworks for pharmaceuticals, both in Sweden and internationally.
- Excellent proficiency in both Swedish and English, with strong communication skills in both written and spoken forms.
- Exceptional attention to detail, organizational skills, and the ability to manage multiple projects with tight deadlines.
- Strong collaborative skills and experience working in cross-functional teams.
- A proactive and solution-oriented mindset with a focus on continuous improvement
- Fluent in English and Swedish.
If this sounds interesting, please send your CV to cv@veritaz.se
