Director Global Regulatory Affairs - CMC

BioNTech; City of London; On-site; GBP 85,000 - 120,000; Full time

Job summary

A leading biotechnology company in London is seeking a Director Global Regulatory Affairs - CMC to lead the regulatory affairs for investigational medicinal products. The ideal candidate will have over 9 years of experience in regulatory CMC globally and a degree in a relevant field. You will define regulatory strategies and collaborate cross-functionally to bring innovative products to market. Competitive remuneration packages are offered.

Benefits

Competitive remuneration packages

Diverse employee support benefits

Qualifications

• More than 9 years professional working experience in Regulatory Affairs CMC globally.
• Extensive experience in preparation and revision of regulatory CMC documents.

Responsibilities

• Lead global regulatory affairs CMC for assigned products.
• Define regulatory CMC dossiers strategy for development and commercial products.

Skills

Excellent communication skills in English

Result-and goal-oriented

Knowledge of CMC drug development

Education

Degree in pharmacy, chemistry, biology, biochemistry, or equivalent

Job description

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Director Global Regulatory Affairs - CMC

Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID:9846

You will lead all aspects of Regulatory Affairs CMC of Investigational Medicinal Products in clinical development. You will bring new medicinal products on the market. As you guide the products along this exciting path, you will establish new regulatory paths and define requirements for these next generation of therapeutics. In your role, you will act globally and work cross-functionally.

Your main responsibilities:

• Act as global regulatory affairs CMC lead for the assigned development and/or commercial products and/or projects and define and execute the Global Regulatory CMC strategy from pre-clinical stage up to Marketing Authorization and/or life cycle maintenance
• Define the strategy of the interactions with national authorities and supra-national regulatory agencies in the scope of CMC aspects for the assigned products. Plan, prepare and conduct all CMC related topics/aspects for the interactions in the scope of products under development up to Marketing Authorization and/or in the life cycle
• Define the regulatory CMC dossiers strategy, content and appropriateness for the respective development and commercial products (lifecycle maintenance); coordinate the preparation, author (e.g. briefing books and CMC sections in the IB) and review the regulatory CMC submission packages incl. sources documents
• Implement and apply as well as adjust and continuously optimize harmonized regulatory CMC processes and systems. Collaborate with internal and external stakeholders using regulatory CMC standards and processes
• Monitor changes and evolution in the regulatory CMC landscape for medicinal products and analyse the impact of changing regulations on BioNTech´s products and/or assigned project

Your Profile:

• Degree in pharmacy, chemistry, biology, biochemistry, or equivalent
• More than 9 years professional working experience in Regulatory Affairs CMC globally during clinical, registration and/or post-marketing for Biologics and/or Vaccines
• Extensive experience in preparation and revision of regulatory CMC documents
• Knowledge of CMC drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing
• Result-and goal-oriented
• Excellent communication skills in English

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech‑Recruiter.

We are looking forward receiving your application.

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BioNTech, the story

At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting‑edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.

Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.

Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!