Head of Regulatory Affairs

Our client is a privately held biotechnology company in Zurich that is seeking a highly motivated Head of Regulatory Affairs for its preclinical to clinical stage transition and beyond.

They are now looking for an energetic and experienced leader with a desire to work in a fast-paced and dynamic international team environment to help build a world class drug discovery company.

The successful candidate will have experience in the dialogue with regulatory bodies (FDA / EMA), previous experience in IND writing and keeps track of required regulatory documents in all stages of the pipeline.

Responsibilities:

- Liaise with regulatory authorities (FDA/EMA)

- Developing and overseeing the implementation of US/EU regulatory strategy

- Organize, control activities required for IND/IMPD submission

- IND/IMPD writing

- Assisting in maintaining compliance with GCP/cGMP standards for early clinical development (from pre-IND meeting to POC clinical development)

- Lead and provide regulatory affairs services to multiple projects in ophthalmology therapeutic area

Experience and requirements:

- At least 8 years of experience in pharma, preferably biotech companies

- Experience in orphan disease area, ocular diseases is a plus

- Experience in leading pre-IND meetings with FDA

- Experience in IND/IMPD/IB writing

- Highly collaborative, self-motivated, team-oriented with outstanding oral and written communication skills in English

Our client offers a competitive compensation package with stock options, incl. benefits, and a thriving workplace with stimulating environment and opportunity to broaden the horizon.

If you are ready for a new challenge and want to be part of a team that will develop breakthrough treatments for degenerative diseases, please apply now!