Regulatory Affairs Manager

vor 4 Wochen

Zürich, Schweiz K-Recruiting Life Sciences Vollzeit

Regulatory Affairs Manager (M/F/D)

Tasks:
  • Defines, develops and leads GEM strategies to maximize regulatory success towards achievement of program objectives.
  • Independently manages, plans and executes all aspects for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product lifecycle management of assigned program.
  • Stays current with regulations/guidances in Growth and Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize positive outcome on the regulatory applications and maintain registration compliance.
  • Provides regulatory expertise on Marketed Products in GEM for multiple projects, focused on non-clinical and clinical aspects of registration and/or post-marketing compliance.
  • Assures ongoing efforts towards fulfillment on international product approval conditions for late stage programs.
  • Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional teams, company’s consultant and Business Partners.
  • Evaluates new business development opportunities for Growth and Emerging Markets and/or participates on due diligence teams.
  • Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required.
  • Represents GEM RA in Health Authority meetings.
  • Effectively communicates and manages meeting outcomes and next steps, as required.
  • Manages, trains, provides direction, strategic guidance and solutions to projects, mentors team members, to support scope of project work.
  • Partners with the regional/Local market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.
  • Responsible for demonstrating leadership behavior.
Qualifications:
  • Bachelor’s degree in a scientific discipline; BA accepted based on experience.
  • Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and/or post-marketing phases.
  • 4 years of directly related regulatory experience is desirable.
  • Solid regulatory experience, including knowledge of regulations and guidances governing drugs and biologics in development and life-cycle management for growth and emerging markets; and US and EU, including interaction with Health Authorities.
  • Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies.
  • Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Generally strong and independent skills in 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.
  • Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership.
  • Effective manager who is able to bring working teams together for common objectives.
  • Experience managing relationships with external vendors and/or contractors is also preferred.
Requirements:

Start: 19.02.2025

Duration: 6 months

Seniority level:

Mid-Senior level

Employment type:

Full-time

Job function:

Other

Industries:

Pharmaceutical Manufacturing

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