Manager Regulatory Affairs
Posted on Nov 18, 2022 by Experis AG
Manager Regulatory Affairs
Candidates from EU who would like to relocate to Switzerland are welcomed
Experis IT is on the search for a Manager Regulatory Affairs to join one of their clients, a well-known international pharma company based in Switzerland.
Contact: Francesca De Chirico
Start Date: ASAP
Duration: 12 Months
Workload percentage: 100%
- Ensures regional regulatory strategies are written, reviewed and executed according to plan.
- In alignment with line manager, provides strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
- Manages, plans, and executes regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and life cycle.
- Partners with the regional market access and colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making.
- May be called upon to provide direction to senior leadership, as relevant.
- Develops and maintains effective working relationships with EUCAN RA and Marketed Product Team members, LOC RA teams, Global Regulatory Teams, Cross-functional Teams; consultants and business partners as required.
- Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility.
- Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.
- In collaborate on with global colleagues, works to resolve regional critical conflicts in global regulatory strategies.
- Authors and oversees execution for more complex regional regulatory strategies as needed.
- Under supervision from a senior team member and/or Line Manager, sometimes leads and manages meetings and/or interactions with regulatory authorities and agency meetings; in alignment with line manager can negotiate on behalf of project team as necessary.
- Under supervision from a senior team member and/or Line Manager, sometimes represents the company in Health Authority meetings, as required.
- Effectively communicates and manages meeting outcome and next steps.
- Pro-actively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support company strategic goals and objectives
- Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
- Ensures coverage for projects within the therapeutic area identifies possible gaps, and proposes solutions to the management
- Presents regional regulatory strategies to senior management as applicable
- A minimum of 6 years of pharmaceutical industry experience. This is inclusive of 5 years of regulatory experience or combination of 6 years regulatory and/or related experience.
- BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
- Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and/or post-marketing phases.
- Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU.
- Understands and interprets complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy.
- Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in the EU region (as relevant to role) with global involvement also preferred.
- Able to understand broad concepts within regulatory affairs and implications across the organization and globally.
- Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
- Experience managing relationships with CROs and/or contractors also preferred.
- Manual dexterity required to operate office equipment (ie computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while travelling.
Don't hesitate and send us your CV and testimonials today through the link in the advert.
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Francesca De Chirico