Regulatory Affairs Associate

You will prepare the documents our programmes need as they move towards the clinic, with a focus on chemistry, manufacturing and controls (CMC).

We welcome recent graduates looking for a job or an internship, and we give priority to those who graduated top of their degree programme or university.

What you will do

• Track the regulatory requirements in each market where a programme will be filed.
• Draft the CMC sections of regulatory documents.
• Gather the data from research, analysis and quality into submissions that hold together.
• Prepare the company for meetings with regulatory agencies.

What you bring

• A degree in pharmacy, chemistry, life sciences or a related field.
• Experience in regulatory affairs or in writing technical documents, from study or from work.
• Knowledge of the ICH guidelines.

Nice to have

• Experience with CMC for biologics or nucleic acid products.
• Knowledge of the regulatory pathways in Asia.

How you can apply

You can apply with the form on this page, or write to our Chief Executive Officer, Marshon Nguyen, on LinkedIn.

Synthena will never ask you for money, for bank details or to install a messaging app while you apply, and our emails come only from synthenapharma.com addresses.