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Regional Regulatory Affairs Manager

Your Role:

As a Regional Regulatory Affairs Manager, you will oversee and coordinate project for the region on a Therapeutic Area Basis.  You will monitor pipeline and development programs, drive capacity requirements and plan and coordinate resourcing capacity for upcoming submissions. You will be responsible for planning scope for HA interaction and reg intelligence and preparing and conducting country roll out by supporting dossier management and document translations. You will act as point of contact for dossier compilation to ensure ready to submit dossier is available as per agreed plan. Within your scope will be conducting internal training on promotional materials and providing relevant support for clinical trials as applicable. You will provide appropriate levels of support, coaching and tools to the team, drive regional strategy cross-functionally for roll outs and  serve as internal point of contact for TA specific questions and requirements. You will infuse regulatory applications/documentation (dossier, promotional material) and manage PSP, IST for marketed products & support management of critical HA notifications e.g. review & document impact of incidents.

Who you are:

  • University degree (Master, PhD) in pharmaceutical science or an equivalent qualification with relevant work experiences
  • 3-5+ years of experience in the regulatory affairs field
  • At least 2 years of supervisory/ managerial experience is preferred.
  • Demonstrated analytical & strategic skills & high affinity to managing/coordinating End to End projects and activities
  • Proven ability of communication and collaboration with stakeholders from different
    backgrounds/functions
  • High proficiency in English is a must, knowledge of additional foreign language will be an asset
  • Flexibility and willingness for business trips

 

Job Requisition ID:  204685
Location:  Mazowieckie - all
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Medical, Pharmaceutical, Regional Manager, Manager, Healthcare, Science, Management

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