Senior Manager, EU Regulatory Lead, Rare Genetic & Hematology in Zürich

veröffentlicht
Kontakt
Audrey Bisch, Basel Professionals Health Care & Life Sciences
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
Zürich
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
18127
Kontakt
Audrey Bisch, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50

Stellenbeschreibung

Our client, based in Zürich, is looking for a passionate Senior Manager, EU Regulatory Lead, Rare Genetic & Hematology for a temporary contract with possibility of extension.

 

Your Responsibilities:

  • Under supervision from a senior team member and/or Line Manager defines, develops and/or leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives
  • Effectively conveys 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, 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 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
  • Partners with Takeda 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, emerging trends, regulations and changes and provides guidance, and expertise to global development team and/or higher governance bodies in these areas
  • May be called upon to provide direction to senior management, 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 needed.
  • Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved within set timeline.
  • Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed
  • In partnership 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, 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, represents Takeda in Health Authority meetings, as needed. Effectively conveys and manages meeting outcome and next steps
  • May be asked 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 Takeda strategic goals and objectives
  • 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

Your Profile:

  • BSc. Advanced scientific related degree preferred; BA accepted based on
  • experience.  Advanced degree preferred
  • Minimum 4 years experience of pharmaceutical industry experience 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 region. Global involvement would be preferred
  • Ability to interpret complex scientific issues across projects and therapeutic area(s) of responsibility
  • Preferred experience in managing multiple filings; or managing multiple programs in closely related development area
  • Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
  • Ability to interpret 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 with senior leadership.
  • Experience managing relationships with CROs and/or contractors also preferred.
 

Do not waste any minutes, apply now!  We are looking forward to receiving your application. 

Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.