Associate Director, Global Regulatory Affairs, CMC Authoring (Remote)

Become a member of the BioNTech Family!

Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence.

With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.


Associate Director, Global Regulatory Affairs, CMC Authoring (Remote)


You will author global quality regulatory documents and provide input into development of regulatory CMC strategy for the assigned projects (e.g., iNeST) in different stages of development, including pre-clinical, Ph I, Ph II, Ph III, initial registration and post-approval stages.



  • Author global quality regulatory documentation for multiple project(s) in a timely manner and according to the relevant procedures.
  • Support definition and establishment of platform approaches to preparation of quality regulatory documentation used in development, registration and post-approval stages
  • Support alignment of structure and contents of quality regulatory documentation across company platforms
  • Contribute to development of regulatory CMC strategy for the assigned project(s)
  • Liaise with relevant stakeholders to facilitate preparation of quality regulatory documentation of the highest quality and strive to optimize/simplify the authoring processes and shorten the authoring times


  • Degree in biochemistry, biology, chemistry, pharmacy or equivalent
  • 5+ years of professional experience in global regulatory affairs CMC focusing on Biologics, Vaccines and/or Small Molecules
  • Extensive experience in authoring of regulatory CMC documents for clinical trial applications (e.g., quality parts of INDs/IMPDs) and/or marketing authorisations (e.g., quality parts of variations, BLAs, MAAs)
  • Solid knowledge of product life cycle management and understanding of scientific principles and regulatory CMC requirements relevant to global drug development
  • Very good knowledge of the relevant laws and guidelines
  • Organisational talent, analytical and conceptual skills as well as excellent communication skills in English (written and spoken)

Benefits for you:

BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

  • Medical, Dental and Vision Insurance

  • Life, AD&D, STD and LTD Insurance

  • HSA & FSA Spending Accounts

  • Health & Wellness, including free onsite gym access

  • Adoption & Surrogacy Assistance

  • Vacation and Unlimited Sick Time

  • Holidays and Floating Holidays, including discretionary winter shutdown

  • 401(K) Plan with Significant Company Match

  • Tuition Reimbursement and Professional Development

  • Commuting Assistance and subsidized parking

  • Discounted Home and Auto Insurance

  • Pet Insurance

Plus more benefits that will be shared upon hire!


Have we kindled your pioneering spirit? 

Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form.

BioNTech does not tolerate discrimination, favoritism, or harassment based on 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!

BioNTech - As unique as you