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.