Regulatory Affairs Manager
CK QLS are recruiting for a Regulatory Affairs Manager to join a Global Pharmaceutical company in their site based in Zurich on a contract basis until September 2021, with the possibility of extension.
Regulatory Affairs Manager Role: The main purpose of the role will be to:
- Lead the regulatory working team for EUCAN region and represents region as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according toplan.
- Define, develop and lead EUCAN regulatory strategies to maximize regulatory success to strengthen the product development plan and to enable patient access in alignment with program objectives.
- Provide regulatory expertise and strategicfocus for assigned development projects and/or marketed product life cycle management to global regulatory team.
- Effectively communicates with stakeholders on objective assessments of the likelihood of success of these regulatory strategies.
Further responsibilities will include:
- Managing, planning and executing the preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program.
- Completing impact assessments of trends, regulations and changes related to assigned programs.
- Supporting preparation activities for meetings with Health Authorities for the assigned program, as required. Interacting directly with HA, as required.
Your Background: In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- BS degree or equivalent in Science; advanced degree preferred.- Sound experience within the pharmaceutical industry, including direct experience in regulatory affairs in post-marketing phases and development.
- Working knowledge of regulations and guidance governing drugs and biologics in development, including post-marketing in EU, including interactions with Health Authorities. A good understanding of basic regulatory requirements in emerging markets is a plus. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies).
- Experience managing relationships with CROs and/or contractors preferred.
This is an excellent opportunity to join a global pharmaceutical company.
Apply: For more information or to apply for this Regulatory Affairs Manager position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email email@example.com, quoting job ref 49347.
Please could you send any correspondence in English.
It is essential that applicants hold entitlement to work in Switzerland.