Ass. Director, GRA Regional TA Lead

TN Switzerland; Opfikon; Vor Ort; CHF 100’000 - 150’000; Vollzeit

Zusammenfassung

An established industry player is seeking an experienced TA Lead for the Cardio-Renal Therapeutic Area. This role involves developing regional strategies and ensuring compliance with regulatory requirements. You will contribute to global regulatory strategies and manage submissions for health authority approvals. The ideal candidate will possess strong leadership and communication skills, along with over 10 years of regulatory experience. Join a dynamic team where your expertise will help shape the future of healthcare and regulatory affairs in a collaborative environment.

Qualifikationen

• 10+ years of regulatory experience with scientific principles.
• Strong leadership and communication skills are essential.

Aufgaben

• Ensure compliance with regulatory requirements and company policies.
• Develop regional regulatory strategies and coordinate submissions.

Kenntnisse

Regulatory Affairs

Leadership

Communication Skills

Adaptability

Ausbildung

Degree in Biological or Medical Science

Post-graduate qualification

Degree in Drug Regulatory Affairs

Jobbeschreibung

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Ass. Director, GRA Regional TA Lead, Opfikon

Client:

CSL

Location:

Switzerland

Job Category:

Other

Job Reference:

a8495248e30e

Job Views:

4

Posted:

25.04.2025

Expiry Date:

09.06.2025

Job Description:

Job Purpose:

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, contributing to global regulatory strategies, and submitting 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.

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 of 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.