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- Aufgaben: Lead regional strategies for regulatory approvals in the Cardio-Renal Therapeutic Area.
- Arbeitgeber: Join CSL, a global leader in biopharmaceuticals dedicated to improving lives.
- Mitarbeitervorteile: Prioritize your well-being with a supportive work culture and flexible options.
- Warum dieser Job: Make a real impact in healthcare while collaborating with global teams.
- Gewünschte Qualifikationen: 10+ years in regulatory affairs; degree in Biological/Medical Science or Pharmacy required.
- Andere Informationen: Opportunity to work in Switzerland and engage with diverse teams.
Das voraussichtliche Gehalt liegt zwischen 120000 - 168000 € pro Jahr.
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Ass. Director, GRA Regional TA Lead, Opfikon
Client:
CSL
Location:
Switzerland
Job Category:
Other
Job Reference:
a8495248e30e
Job Views:
9
Posted:
21.01.2025
Expiry Date:
07.03.2025
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:
- Ensure compliance with CSL’s Code of Responsible Business Practice, Global Policies, and GRA Business Process Framework.
- Be a Subject Matter Expert on regional regulatory procedures and Health Authority (HA) requirements.
- Develop regional regulatory strategies, participate in GRA Strategy Team (GRAST) meetings, and contribute to complex project strategy documents.
- Coordinate submissions, responses to HA questions, and participate in Scientific Advice Meetings.
- Report to the Global Regulatory Affairs, Head Region Intercontinental.
Qualifications:
- Degree in Biological or Medical Science or Pharmacy (preferably with a post-graduate qualification). Degree in Drug Regulatory Affairs is advantageous.
- 10+ years of regulatory experience of scientific principles, and familiarity with GMP, GCP, and GLP.
- 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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Ass. Director, GRA Regional TA Lead, Opfikon Arbeitgeber: TN Switzerland
Kontaktperson:
TN Switzerland HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Ass. Director, GRA Regional TA Lead, Opfikon
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements in the Intercontinental region. Understanding the nuances of regional regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience in the Cardio-Renal Therapeutic Area. Engaging with industry peers can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in global regulatory policies. Being knowledgeable about current events in the regulatory landscape will position you as a proactive candidate during discussions.
✨Tip Number 4
Prepare to discuss your leadership experiences in detail. Highlight specific instances where you've successfully led teams or projects, as this is crucial for the TA Lead role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Ass. Director, GRA Regional TA Lead, Opfikon
Tipps für deine Bewerbung 🫡
Understand the Role: Take the time to thoroughly understand the responsibilities and qualifications required for the Ass. Director, GRA Regional TA Lead position. Tailor your application to highlight your relevant experience in regulatory affairs and leadership.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 10+ years of regulatory experience, particularly in the Cardio-Renal Therapeutic Area. Provide specific examples of how you've developed regional strategies and managed submissions to Health Authorities.
Showcase Leadership Skills: Demonstrate your leadership abilities by including examples of how you've led teams or projects in the past. Mention any experience you have in coordinating with Global and Local Regulatory Teams.
Proofread Your Application: Before submitting your application, carefully proofread your documents to ensure there are no errors. A well-presented application reflects your attention to detail, which is crucial in regulatory affairs.
Wie du dich auf ein Vorstellungsgespräch bei TN Switzerland vorbereitest
✨Show Your Expertise
Make sure to highlight your extensive experience in regulatory affairs, especially in the Cardio-Renal Therapeutic Area. Be prepared to discuss specific examples of how you've developed regional strategies and navigated complex regulatory environments.
✨Demonstrate Leadership Skills
Since this role requires strong leadership, share instances where you've successfully led teams or projects. Emphasize your ability to adapt and communicate effectively with both local and global teams.
✨Understand Compliance Requirements
Familiarize yourself with CSL's Code of Responsible Business Practice and other relevant global policies. Be ready to discuss how you ensure compliance in your previous roles and how you would approach compliance in this position.
✨Prepare for Technical Questions
Expect questions related to GMP, GCP, and GLP. Brush up on these topics and be ready to explain how your knowledge has been applied in real-world scenarios, particularly in relation to Health Authority submissions.
