Regulatory Scientist, Global Regulatory Affairs
CK QLS are recruiting for a Regulatory Scientist to join a global pharmaceutical company at their site based just outside for Basel, in Allschwil. This role is offered on a 9 month maternity cover role.
Regulatory Scientist, Global Regulatory Affairs Role: The main purpose of the role will be to provide support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, includingassuring that content and intent of regulatory filings support the global regulatory strategy.
Key responsibilities will include:
- Participating in global regulatory team meetings as appropriate.
- Advising the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned.
- Liaising with Regulatory Agencies and Local Operating Companies.
- Assisting in the preparation of meetings with Regulatory Agencies.
Further responsibilities will include:- Reviewing clinical trial plans and protocols and ensure alignment with regulatory requirements.
- Advising team in required documents and submission strategies (in collaboration with LOCs as appropriate) including Health Authority Submissions (e.g. Briefing Books, Scientific advice packages, Marketing Authorization Applications (MAAs), New Drug. Applications (NDAs) or equivalent regional or national documents).
Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- University degree - Medical or Paramedical (Pharmacy, Biology, Veterinary etc.) or equivalent by experience.
- Previous experience working in is regulatory affairs, desirable.
- Understanding of the drug development process and regulatory submission and approval process.
- Knowledge of the regulatory environment, guidelines and practices of region.
- Previous experience in Pulmonary Hypertension / Orphan Diseases would be advantageous.
This is an excellent opportunity to join a global pharmaceutical company and gain invaluable experience.
Apply: For more information or to apply for this Regulatory Scientist, Global Regulatory Affairs position, please contact Jocelyn on 0041 (0) 782 516 595 or email email@example.com, quoting job ref 51208.
It is essential that applicants hold entitlement to work in Switzerland.