Ass. Director, Gra Regional Ta Lead

We are looking for an experienced TA Lead / Team Lead for the Cardio-Renal Therapeutic Area in the Intercontinental (ICO) Region. You will develop regional strategies, contribute to global regulatory strategies, and submit regulatory applications for development products and change applications for registered products to obtain Health Authority (HA) approval in the fastest way. You will ensure compliance with regional regulatory requirements, manage issues, and support efforts to establish effective working relationships with Global and Local Regulatory Teams, and with other important partners including from other functions.

Main Responsibilities:

1. Ensure compliance with CSL\’s Code of Responsible Business Practice, Global Policies, and GRA Business Process Framework.
2. Be a Subject Matter Expert on regional regulatory procedures and Health Authority (HA) requirements.
3. Develop regional regulatory strategies, participate in GRA Strategy Team (GRAST) meetings, and contribute to complex project strategy documents.
4. Coordinate submissions, responses to HA questions, and participate in Scientific Advice Meetings.

You will report to the Global Regulatory Affairs, Head Region Intercontinental.

The position is based in Switzerland.

Qualifications:

1. Degree in Biological or Medical Science or Pharmacy (preferably with a post-graduate qualification). Degree in Drug Regulatory Affairs is advantageous.
2. 10+ years of regulatory experience with scientific principles, and familiarity with GMP, GCP, and GLP.
3. Demonstrated leadership, adaptability, and excellent communication skills.

We encourage you to make your well-being a priority. It’s important and so are you.

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