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Team Lead Regulatory Affairs Regions(m/w/x)

Merz Therapeutics
Frankfurt am Main

You lead a regional regulatory affairs team, ensuring compliance and performance while collaborating with global teams on submissions and interactions with authorities. Your role includes assessing risks and supporting process improvements.

Anforderungen

  • •University degree in natural sciences
  • •10+ years in regulatory affairs
  • •5+ years of line management experience
  • •Comprehensive knowledge of regulatory frameworks
  • •Experienced in project management
  • •Analytical and strategic thinker
  • •Solution oriented team player
  • •Excellent communication skills in English

Deine Aufgaben

  • •Lead a regional team and ensure compliance.
  • •Drive performance and optimize regulatory processes.
  • •Ensure local input for global submissions.
  • •Respond timely to authority requests with global teams.
  • •Maintain licenses and update milestones promptly.
  • •Align regional input with global strategy.
  • •Coordinate key interactions with authorities.
  • •Assess regional risks and opportunities for acquisitions.
  • •Support departmental goals and process improvement.

Deine Vorteile

Individual career development
Hybrid work model
Attractive location with transport links
Global family business culture
Attractive remuneration with benefits
Employer-subsidized benefits

Original Beschreibung

Team Lead Regualtory Affairs Regions (m/f/d) **YOUR CONTRIBUTION** In the role of **Team Lead Regulatory Affairs Regions (m/f/d)**, you contribute to the development and success of the Merz Therapeutics organization. You lead a team of 10 professionals, ensuring timely and compliant execution of regional regulatory activities across the product lifecycle. You drive process optimization and collaborate closely with affiliates, partners, and CROs. You provide regulatory expertise and actively support the development of your team. Your main responsibilities include the following activities: * Lead a regional team, ensure compliance, drive performance, and optimize regulatory processes across licenses, budget, and organization * Ensure local input for global submissions and timely response to authority requests in collaboration with global teams * Ensure license maintenance and timely milestone updates to support global regulatory reporting * Align regional input with global strategy and coordinate key authority interactions * Assess regional risks and opportunities for product acquisitions * Support departmental goals, collaboration, and process improvement **YOUR PROFILE** * University degree in natural sciences studies, preferrable pharmacy, biology, chemistry or equivalent * 10+ years in regulatory affairs or in the pharmaceutical industry exposed to developmental activities involving clinical, quality and non-clinical tasks * 5+ years of line management experience in a global pharmaceutical industry and the ability to lead an international team * Comprehensive knowledge of international regulatory environment and frameworks and ideally regional regulatory experience for 2 region * Experienced in project management and budget control * Analytical and strategic thinker with compliancy & quality mindset * Solution oriented team player paired with strong negotiation skills * Excellent communication skills in English, German is a plus **YOUR BENEFIT** * Individual career development in a purposeful job: you improve the quality of life of our patients! * Hybrid work model (50:50) that allows a good work-life balance * Attractive location with good transport links, modern workplaces and a company restaurant * Global family business with flat hierarchies and an open, respectful corporate culture * Attractive remuneration with extensive social benefits * Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike
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