Director Global Regulatory Affairs

BioNTech SE; Deutschland; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

A biopharmaceutical company in Mainz, Germany is seeking a Global Regulatory Lead to define and execute regulatory strategies for development projects. The ideal candidate has over 9 years of experience in Regulatory Affairs, particularly in cancer therapies, and is fluent in English. This is a full-time role that offers competitive remuneration and a commitment to employee wellbeing.

Leistungen

Competitive remuneration packages

Support for diverse employee needs

Qualifikationen

• 9+ years of working experience in Regulatory Affairs.
• Experience in antibody- and ADC-based cancer therapies.
• Proven ability to plan and lead activities in regulatory strategy.

Aufgaben

• Act as Global Regulatory Lead for assigned projects.
• Define regulatory interaction strategies with authorities.
• Monitor and analyze changes in the regulatory landscape.

Kenntnisse

Regulatory strategy planning

Team-oriented mindset

Solution-oriented mindset

Knowledge of drug development functions

Fluent English

Ausbildung

University degree in natural sciences

Jobbeschreibung

Mainz, Germany | full time | Job ID: 9340

You will act as the Global Regulatory Lead for assigned development projects by defining and executing the Regulatory Strategy including the Health Authority Interaction strategy and developing the storyline for regulatory applications and dossiers during product development up to marketing authorization (optional: act as US IND agent for assigned projects).

Your main responsibilities are:

• Act as Global Regulatory Lead for assigned development projects and define and execute the Regulatory Strategy from clinical development up to (including) marketing authorization.
• Define the strategy for regulatory interactions for the assigned projects. Plan, prepare and conduct interactions with national authorities and sovra-national agencies (e.g. MPA, PEI, EMA, FDA, as well as WHO when relevant) in the scope of product development incl. market authorization.
• Define the storyline for regulatory applications and dossiers through product development up to marketing authorization.
• Coordinate preparation, writing and reviewing of documents and dossiers (e.g. briefing books, IBs, BLA/MAA).
• Contribute to the setup, adjustment and continuous optimization of regulatory processes, systems and interfaces; represent GRA in cross-functional initiatives for process improvement and with collaboration partners
• Supervision of vendors active in regulatory affairs on behalf of BioNTech.
• Monitor changes and evolution in the regulatory landscape for relevant product and/or product classes; analyze the impact of new regulations on assigned projects; contribute to build transparent relationships with Regulatory agencies for the assigned projects.

What you have to offer:

• University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent) followed by 9+ years of working experience in Regulatory Affairs in relevant roles/positions

• Experience in the development of antibody- and ADC-based cancer therapies; novel-novel combination therapy and companion diagnostic development experience a plus

• Team-oriented and solution-oriented mindset is expected

• Experience in regulatory strategy planning and proven ability to plan, coordinate and lead activities

• Knowledge of multidisciplinary functions involved in drug development

• Business fluent English is a must

Your Benefits:

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.

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