Beschreibung
Global Program Regulatory ManagerLocation: Basel
Duration: 6 months initially
Our client, one of the leading companies within the Life Sciences worldwide is currently seeking a Regulatory Affairs Manager.
As a Regulatory Affairs Manager you will work independently under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team representative and/or therapeutic area lead for programs through development, registration and approval/post approval.
Tasks:
- Ensure the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team representative and/or therapeutic area lead.
- Provide input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
- Partners with regions to align on regulatory strategy in order to fulfil business objectives
- Develop and implement regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders, and ensures integration with global regulatory readiness with RA representative and/or therapeutic area lead.
- Determine requirements and set objectives for Health Authority (HA) interactions with RA representative and/or therapeutic area lead.
- Lead rehearsals for HA meetings as appropriate.
- Review of global dossier summary documents.
- Review, approve and submit Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
- Review and submit Risk Management Plans.
- Contribute to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA representative and/or therapeutic area lead, consistent with development data and commercial objectives.
- Identify potential label issues/gaps and develop regulatory label negotiation strategy with contingency planning.
- Responsible for finalization and on time submission of annual reports and renewals across assigned regions.
Requirements:
- Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
- Strong knowledge of regulatory submission and approval processes in 1 or more major regions.
- Experience leading regulatory submissions and approvals in at least 1 major region.
- Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry
- Experience in HA negotiations.
- Over 3 years of involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: o Innovation in regulatory strategy.
- Prior history with post-marketing/brand optimization strategies and commercial awareness preferred.
- Involvement in dossier submissions and approvals.
- Languages: Fluency in English as a business language. Additional language is an asset.
- Relevant working/residency permit or Swiss/EU citizenship required
I am a specialized recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word format including your hourly rate expectations for immediate consideration.
You can reach me on .
Keywords: Regulatory Affairs, RA Manager, RAM, Pharmaceuticals, CTA, Clinical Trials, Switzerland, English, DCDS, INDs, Global, International
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.