Regulatory Affairs Manager (Budapest)

Regulatory Affairs Manager (Budapest)
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Regulatory Affairs Manager

 

Your new company

We are looking for a Regulatory Affairs manager to lead a small team and supervise regulatory affairs of our innovative pharmaceutical partner in Budapest. 6+ years’ extensive regulatory experience at an innovative company and people management background is desirable.

 

Your new role

  • First point of contact for interactions with local regulatory agency
  • Ensure that the local Regulatory staff in the country delivers on local and/or regional regulatory and compliance strategies/goals across their country
  • Represent Regulatory Affairs on the country management team
  • Senior point of contact for regulatory advice on commercial and medical projects within the affiliate.
  • Contributes to the filing plan (MA and Lifecycle maintenance), advising and discussing with own team and local cross-functional team.
  • Executes the filing plan (MA and Lifecycle maintenance) for their country
  • Ensures regulatory submissions are made on time and meet company’s corporate and local regulatory requirements
  • Creates, reviews and approves source text for country labelling, and owns the country artwork based on source text
  • Reviews and approves the promotional and non-promotional materials
  • Monitors changes in the local Trade Associations / national legislation and forwards information to local/regional groups communicating the impact to company
  • Monitors the external regulatory environment to help inform/advise in the regulatory decision making
  • Oversees the affiliate / local office compliance framework to comply with local codes and legislation and company policies and procedures
  • Provides advice, guidance and support to Regulatory staff.
  • Recruits and retain talented regulatory staff.
  • Provides coaching, mentoring and development of Regulatory staff.
  • Is accountable for delivery against goals assigned to the country
  • Provides input to budget and headcount planning
  • Leads/Participates in local regulatory process improvements, initiatives, and trainings
  • Tracks metrics for team deliverables.
  • Ensures approval and maintenance of local products, clinical trials and pharmaceutical company licenses.

 

What you need to succeed

  • Master’s degree
  • At least 6 years’ experience in Regulatory Affairs in pharmaceutical company, preferably in innovative company; people management experience
  • Fluency in Hungarian and English languages
  • Deep knowledge of country legislation and regulations relating to medicinal products
  • Ability to lead teams and develop effective teams
  • Availability for 1-year fixed-term contract (possibly can be indefinite in the long run)

 

What can you expect from our partner

  • Stable, leading biotechnology company
  • Competitive compensation package
  • Flexible working solution


What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

Budapest

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