Job Description

Become a member of the BioNTech Family!

As a part of our team of more than 4.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people\'s lives.

Site Regulatory Manager*

Provide strategic and operational regulatory and CMC expertise with focus on local Singapore regulatory requirements for biological medicinal products, including vaccines.

Accountable to work with the Global Regulatory (CMC) Lead, Global Quality and other stakeholders to establish processes to ensure receiving marketing authorizations for global/local products in Singapore and other Authorities, as needed. Primary point of contact for local authorities.

Your main responsibilities are:

• Close collaboration to the global regulatory organization to ensure implementation of the global strategy for new marketing authorizations and lifecycle management activities.
• Point of Contact (PoC) with local Singapore authorities.
• Preparation of local documentation for upcoming site-specific submissions (manufacturing licenses, export and import licenses etc.) and product-specific submission (INDs, CTAs, MAAs, BLAs, variations etc.)
• Act as local/regional Regulatory CMC Expert as part of the Singapore Site and link to the global Regulatory Affairs organization.
• Assess the local requirements and determine the optimal regulatory strategy for local authorizations in alignment with the Global Regulatory Lead (GRA) and GRA CMC Lead, execute regulatory strategy to enable manufacturing at the local site in Singapore.
• Plan, prepare and conduct interactions with Health Authorities as appropriate in coordination with GRA (CMC) Lead.
• Ensuring alignment between regulatory objectives and project timelines
• Monitor regulatory and competitive landscape in Singapore; analyze the impact of regulation changes for BioNTech\'s products; collect, evaluate and disseminate relevant updates as appropriate. Provide regulatory advice to global stakeholders in support of strategy development.
• Manage regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments on deviations, CAPAs, change controls, etc, as appropriate.
• Close collaboration to the global regulatory organization to ensure that local processes are in line with global defined standards and strategies.

What you have to offer:

Education:

University degree in natural sciences (medicine, pharmacy, chemistry, biotechnology, biology or equivalent).

Professional experience and skill:

• At least 6 years professional working experience in Regulatory Affairs, including CMC, during clinical development, registration and post-marketing for Biologics and Vaccines
• Experiences in interactions with Singapore authorities and other APAC Authorities
• Profound knowledge in global and local (CMC) regulatory regulations (Singapore, APAC etc.)
• Extensive experience in preparation and revision of regulatory documents, incl. CMC, local labelling and artworks
• Knowledge of drug development (with focus on CMC Drug Substance and Drug Product) and manufacturing.
• Experiences with collaborations with global multidisciplinary functions involved in drug development and manufacturing.
• Strong understanding of pharmaceutical business and regulatory governance/framework

Languages:

Fluency in English (written and spoken) is essential

Competencies:

• Pronounced team & communication skills; Ability to be agile and effectively collaborate in a dynamic, cross-functional environment.
• High degree of conscientiousness and diligence
• Constructive work habits, flexibility, solution orientation, job ownership, quality awareness, and very good planning and organizational skills in a fast-paced environment
• Self-starter and learning capacity
• Sense of ownership and honesty (proactive handling of errors)
• Ability to navigate through ambiguity and rapid growth and adapt to change
• Strong problem-solving skill, solution-oriented, and being able to work at start-up environment and manage ambiguity and operate effectively

Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate\'s qualifications and experience.

How to apply:

Apply now and simply send 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 by using our online form.

Please note:

• Only applications sent via our online form shall be considered.
• Only Candidates with the right qualifications and relevant experience shall be shortlisted and
• Incomplete applications shall be rejected.
• Please note that BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it\'s a match!

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