Head of Regulatory Affairs

Geneva Permanent
  • Head of Regulatory Affairs position for Biosimilars Business Unit
  • Well known global company in healthcare sector

About Our Client

Well known global company in healthcare sector

Job Description

  • Responsible for directing global regulatory strategies for assigned projects and programs.
  • Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
  • Provide regulatory guidance to company personnel throughout the research and development process, approval and post approval phases
  • Direct the organization and preparation of clear and effective submissions.
  • Prepare and deliver effective presentations for external and internal audiences.
  • Monitor and analyze appropriate regulatory agency activities in areas of interest to the company.
  • Develop and maintain highly capable and dedicated regulatory staff. Guide subordinates in carrying out responsibilities. Responsible for coordinating subordinate activities and career development.
  • Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
  • Coordinate relations and alignment with local/regional regulatory experts inside the company
  • Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
  • Ensure sufficient resources and support is allocated to the projects teams
    Provide and maintain consolidated portfolio planning of regulatory relevant key project activities (briefing book, IND/IMPD updates, consultations, submission,…)
  • Create and maintain a network of regulatory experts that allows to continuously maintain a high level of knowledge within the company and provide a reliable platform of challenges for the projects in development
  • Provide input to Regulatory Senior Management teams.
  • Foster a global view as part of the whole regulatory team
  • Take steps to actively improve interdepartmental communications.
  • Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
  • Is likely to have presence on external regulatory committees/trade associations.
  • Analyse the competitive landscape in development from a regulatory perspective.
  • Ensure regulatory submission relevant tools are appropriate and adequate
  • Direct global clinical and pre-clinical regulatory strategies.
  • Direct global life cycle management of products.
  • Actively promote relationship building between the ROW team, distributors and commercial teams
  • Direct the ROW filing strategy for new submissions
  • Develop, motivate and ensure personal within regulatory department is highly skilled and provide an adequate support to the business unit needs

The Successful Applicant

  • Minimum of 15 years pharmaceutical/biotechnology industry experience with technical management experience.
  • Minimum of 15 years in Regulatory Affairs.
  • Good knowledge of applicable regulations.
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Experience in European regulatory pathways for Biosimilars and previous experience in filing Biosimilars.
  • Experience with FDA is a significant plus
  • Experience in interfacing with relevant regulatory authorities.
  • Foster effective, positive interactions with regulatory agencies, and corporate partners.
  • Ability to lead and influence project teams, committees, etc. to attain group goals.
  • Demonstrate excellent leadership and communication skills.
  • Ability to represent the department in project teams, committees and external meetings.
  • Demonstrate strong organizational skills, including the ability to prioritize personal workload.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
  • Customer orientation with open minded and strategic thinking beyond on function
  • Able to handle and oversee multiple tasks simultaneously and prioritize in a meaningful manner
  • Strong sensitivity for a multicultural/multinational environment. Experience leading multi-disciplinary teams.
  • Well organized, detail oriented, effective written and oral communication skills.
  • Supervisory experience.
  • Ability to guide, train, develop, supervises and motivate and prioritizes workload of direct reports.

What's on Offer

Great carreer opportunity

Erman Kilincoglu
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Job summary

Policy, Economics & Regulatory Affairs
Policy, Economics & Regulatory Affairs Subsector
Life Sciences
Contract type
Consultant name
Erman Kilincoglu
Job reference

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