- CH-Zurich/remote
- Applications have closed CH-Zurich/remote02.12.202431.05.2025100 % 960rate negotiableDeadline
12.11.2024
For our customer located in Zurich/Switzerland we are currently looking for a: Regulatory affairs lead EUCAN GI and inflammation (m/f/x)
- Location: Zurich/remote (5 days in the office per month, remaining days remote possible)
- Branch: Pharma
Background:
Under supervision from a senior team member and/or Line Manager defines, develops and sometimes leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives
Effectively communicates objective assessments of the likelihood of success of these regulatory strategies
Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements
Leads the Regional Working Team and represents the region as needed on global and project teams
Provides regional regulatory expertise for assigned development and /or life cycle management projects within the therapeutic area of responsibility
Under supervision from a senior team member and/or Line Manager sometimes manages interactions with EMA and national health authorities (and HTAs in context of parallel consultation) in the European Region for product(s) within their responsibility.
Tasks & Responsibilities
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 lifecycle
Partners with the regional market access and LOC RA 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
Collaborates with Global and Regional counterparts and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed upon for all projects within area of responsibility
Identifies relevant regional regulatory requirements and trends across scope of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas
Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to area and region of responsibility
May be called upon to provide direction to senior leadership, as relevant
Develops and maintains effective working relationships with EUCAN RA and Rare Genetic & Hematology 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 collaboration 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 client in Health Authority meetings, as required.
Effectively communicates and manages meeting outcome and next steps
May be required to lead and provide regional regulatory input in due diligence for licensing opportunities, development and /or marketed products
Pro-actively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support the clients 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
Must Haves
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
Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
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.
Generally strong in working well with others, within global teams and communicating with senior leadership.
Takes stand on important issues in productive, respectful way.
Experience managing relationships with CROs and/or contractors also preferred
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.