For our customer located in Basel/Switzerland we are currently looking for a: Regulatory Affairs Manager (m/f/d)
- pay rate range: 55.77 CHF/h – 83.65 CHF/h
- Duration: 12 months
- Remote work: No, ideally worker should comply with our clients policy (12 days/months minimum in the office)
Tasks & Responsibilities
- Responsible for managing operational activities of assigned early development projects.
- Responsible for organizing and planning submission team meetings, driving regulatory timelines and with input from the EDRDs and franchise DRA may lead key messaging for ED submissions and HA responses.
- Provides input into global regulatory strategy and contributes to the Integrated Development Plans (IDP) and early Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
- Partners with regions and franchise DRA to align on regulatory strategy for ED programs, assuring full awareness of franchise and regional experts in plans and timing for programs to move to PoC and full development.
- Works with the ED DRA Head and EDRDs to plan and facilitate presentations to our clients regulatory boards on regulatory strategy.
- Works with DRA ED Head, EDRDs and/or GTAL in the relevant therapeutic area to obtain needed external input from consultants and advisors for specific program challenges.
- Represents DRA on or leads sub-teams as required.
HA Interactions:
- Works with EDRDs to determine requirements and set objectives for Health Authority (HA) interactions.
- Interacts directly with HAs as appropriate in meetings with input and support from DRA EDRDs or franchise leadership.
- Coordinates and plans rehearsals for HA meetings.
- Develops and implements plans for timely response to HA requests and coordinates responses.
- May serve as local HA liaison depending on location (e.g., FDA or EMA).
Must Haves
- Education: Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) is a plus. Background in basis science or toxicology is preferred.
- Fluency in English as a business language. Additional language is an asset.
- Experience with regulatory submission and approval processes in 1 or more major regions.
- Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.
- Experience in HA negotiations.
- minimum of 2-4 years involvement in regulatory and drug/biologic development spanning activities in Early Development and Phases I-IV
- Strong interpersonal, communication, negotiation and problem solving skills.
- Experience in the following areas will be helpful.
– Innovation in regulatory strategy.
– Research experience in biology, pharmacology, toxicology, DMPK or Chemistry.
– Experience with biologics is a plus.
– Analysis and interpretation efficacy and safety data.
– Regulatory operational expertise. - Basic organizational awareness (e.g., interrelationship of departments, business priorities).
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.