Manager Global Regulatory Affairs Development Pipeline

BioNTech SE; Deutschland; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A leading biotechnology company in Germany is seeking a Regulatory Affairs professional to support the Global Regulatory Affairs Development Pipeline team. The role involves contributing to regulatory activities from clinical development to marketing authorization. Candidates should have at least 3 years of experience in Regulatory Affairs and a university degree in natural sciences. This position offers competitive remuneration and a dynamic workplace focused on innovation.

Qualifikationen

• At least 3 years professional working experience in Regulatory Affairs.
• Experience in clinical trial initiation and maintaining regulatory procedures.

Aufgaben

• Support the Global Regulatory Lead in executing regulatory strategies.
• Prepare and conduct interactions with national authorities.
• Coordinate the preparation and review of regulatory documents.

Kenntnisse

Fluent command of spoken and written English

Attention to detail

Good interpersonal and organizational skills

Ability to work in a multi-cultural international environment

Ability to think 'analytically' and convey complex concepts

Ausbildung

University degree in natural sciences

Tools

Standard office software (Word, Excel, Adobe Acrobat)

Electronic document management technology

Jobbeschreibung

Overview

Mainz, Germany; Cambridge, US; London, United Kingdom; Munich, Germany | full time | Job ID: 9671

Role

You will support the Global Regulatory Affairs Development Pipeline team in the creation and review of regulatory documents and dossiers throughout product development up to marketing authorization.

Responsibilities

• Support the Global Regulatory Lead for assigned development projects in executing the defined regulatory strategy from clinical development up to marketing authorization, contributing to regulatory activities and tasks and ensuring good documentation practice
• Support the Global Regulatory Lead in the preparation and conduct of 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. marketing authorization. Manage the documentation of regulatory interactions, incl. meeting minutes and correspondence
• Coordinate the preparation, writing, and reviewing of documents and dossiers (e.g. briefing books, IBs, CTA/IND, MAA)
• Contribute to the setup, adjustment and continuous optimization of regulatory processes, systems and interfaces
• Supervise vendors active in regulatory affairs on behalf of BioNTech
• Regulatory Intelligence: Contribute and monitor changes and evolution in the regulatory landscape for therapeutics and/or diagnostics. Analyze the impact of drug/devices changing regulations for BioNTech's products

What you have to offer

• University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent)
• At least 3 years professional working experience in Regulatory Affairs incl. clinical trial initiation and maintenance, regulatory procedures and requirements
• Fluent command of spoken and written English
• Advanced computer skills, in particular good knowledge of standard office software (Word, Excel, Adobe Acrobat) and electronic document management technology
• Good interpersonal and organizational skills
• Ability to work in a multi-cultural international environment
• Ability to think 'analytically' and convey complex concepts in an understandable manner
• Attention to detail

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.

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!

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