At a Glance
- Tasks: Lead CMC regulatory strategies and oversee submissions for transformative medicines.
- Company: Join Moderna, a pioneering biotech company dedicated to innovative healthcare solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Fast-paced environment with dynamic projects in vaccines, oncology, and rare diseases.
- Why this job: Make a real impact in global health by ensuring compliance for groundbreaking therapies.
- Qualifications: 10+ years in pharma/biotech with strong CMC regulatory experience required.
The predicted salary is between 63000 - 77000 £ per year.
The Role Moderna is looking for a Associate Director, CMC Regulatory Affairs-International, to join our team based in London, UK.
This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the development of global products.
The successful candidate will lead and support all regulatory activities, ensuring the delivery of high-quality CMC sections of regulatory documentation.
This role demands a dynamic individual capable of managing multiple projects in a fast and results-oriented environment, dedicated to bringing a new generation of transformative medicines to patients.
Here’s What You’ll Do Developing and implementing effective CMC regulatory strategies for international submissions (e. g., IND/CTA/BLA/MAA) and identifying regulatory risks.
Providing guidance on regulatory CMC aspects of product development projects.
Reviewing documents for submission readiness, ensuring conformity to health authority guidelines.
Leading Regulatory CMC discussions and interactions with health authorities to facilitate the review and approval of submissions.
Developing regulatory processes and procedures to support the CMC components of regulatory submissions.
Your responsibilities will also include Supporting the creation and maintenance of CMC submission templates.
Providing CMC regulatory guidance to manufacturing and quality teams; evaluating CMC change controls.
Offering interpretations of regulatory guidance documents, regulations, and directives, advising on their applicability and impact on internal programs.
Leading oversight of multiple programs in various therapeutic areas (vaccines, oncology, and/or rare diseases).
The key Moderna Mindsets you’ll need to succeed in the role Pursue options in parallel: This role requires a strategic thinker who can explore multiple avenues simultaneously to ensure the most efficient and effective regulatory strategies.
Act with urgency: Given the fast-paced and result-oriented environment, acting swiftly and decisively is crucial to meet deadlines and deliver transformative medicines to patients.
Here’s What You’ll Need (Basic Qualifications) BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus 8+ years of experience in Biologics focused Regulatory CMC Multidisciplinary focus on certain therapeutic areas (vaccines, oncology and/or rare diseases) Strong knowledge of current EU and ROW regulations Strong knowledge of Cgmp Strong experience with CTD format and content regulatory filings Exceptional written and oral communication Pay
Associate Director, CMC Regulatory Affairs, International employer: Meeveem Limited
Meeveem Limited is an exceptional employer that values its employees by fostering a collaborative and innovative work culture in the heart of Yorkshire. With a strong focus on professional development, employees are encouraged to grow their skills and advance their careers while enjoying competitive benefits and a supportive environment that prioritises work-life balance. Joining Meeveem means being part of a dynamic team dedicated to making a meaningful impact in the cardiovascular and endovascular sectors.
