(Senior) Regulatory Affairs Manager

Firmenname für PREMIUM-Mitglieder sichtbar

  • Januar 2023
  • Januar 2024
  • CH-Zürich | CH-8000 Zürich
  • auf Anfrage
  • 13.01.2023
  • RE-34001014_1673622675

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Projektbeschreibung

Regulatory Affairs Manager

Duration: 12 months initially

Location Zurich (hybrid working model)

Tasks:

* 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.
* 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.
* 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 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
* 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 Oncology 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.
* 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 company in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps.
* May be required to 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 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

Qualification:

* 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
* Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in either EU or US region (as relevant to role) with global involvement also preferred
* Able to train/develop junior colleagues in the area of regulatory strategy such as understanding 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.

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

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