Senior Regulatory CMC Manager – 10321

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in securing the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry.
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.