Regulatory Manager

  • BioNTech Careers
  • Singapore
  • Work experience
  • Quality Management, Quality Assurance
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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.

Regulatory Manager*

Provide strategic and operational regulatory expertise with focus on Singapore which includes in-
formation to register a new vaccine. Accountable to work with the Global Regulatory Lead and
Global Quality to develop a valid process and deliver marketing authorizations for our products in
Rwanda. Primary point of contact for local related authorities.

Your main responsibilities are:
  • Close collaboration to the global regulatory organization to ensure that local processes are in line with global defined standards and strategies
  • Initial contact with local Singapore authorities
  • Preparation of 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 Regulatory Expert as part of the Singapore Site and linked to the global Regulatory affairs organization
  • In alignment with the Global Regulatory Lead (GRA) , define and execute regulatory strategy to enable manufacturing in Singapore; assess the requirements and determine the regulatory strategy
  • Act as primary point of contract to local official authorities on behalf of BioNTech ensuring alignment between objectives and timelines
  • Plan, prepare and conduct interactions with Health Authorities as appropriate in coordination with GRA leads
  • 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.
  • Refine existing processes to continuously improve organizational efficiency for Singapore

What you have to offer.

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

Professional experience:
  • At least 8 years professional working experience in Regulatory Affairs CMC during clinical, registration and/or post-marketing for Biologics and Vaccines
  • Experiences in interactions with Singapore authorities and WHO as well as profound knowledge in Singapore and WHO regulations
  • Extensive experience in preparation and revision of regulatory CMC documents; Knowledge of CMC drug development (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.

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 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 (criminal record certificate) in case you do not provide one.

We are looking forward receiving your application.

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!