Director Regulatory Affairs

Director Regulatory Affairs

ProPharma Group

Stockholm, Sweden

Job Description

The Director, Regulatory Affairs will formulate regulatory strategies and recommendations for the resolution of complex issues for clients and will lead the process in the development of regulatory submission, including but not limited to; MAA’s, Orphan, and PIP applications, Accelerated and Conditional approvals. They will conduct due diligence on behalf of clients and develop risk management recommendations, build collaborative relationships with key stakeholders and manage the internal and external teams.

  • Leading the development and implementation of regulatory strategies to realize the commercialization of healthcare products.
  • Lead the regulatory activities
  • Strategic project shaping and leading of process preparation for EMEA submissions.
  • Review and approval of audit and submission documentation.
  • Briefing of clients and internal project teams.
  • Leading and influencing frequent interactions for pre-submission activities with both EMA and national regulatory agencies.
  • Project manager role with coordination of other activities, such as promotional material and PV.
  • This position does not involve line management.

Qualifications

  • Postgraduate degree in a life sciences discipline.
  • Minimum of 5 years Regulatory and EMEA submission experience.
  • Strong RA experience with the possibility to oversee clinical development programs.
  • Strong RA product management experience.
  • Ability to handle commercial aspects such as MAH transfers, variations and EMA interactions.
  • Excellent knowledge of the pharmaceutical industry.
  • Strong scientific and analytical ability.
  • Keen consultancy skills in handling clients.
  • Ability to manage organizational change.
  • Oncology, haematology, orphan diseases and immunology experience preferred.
  • Excellent interpersonal skills.
  • Sharp attention to detail.
  • Flexibility to move quickly between projects and work across different therapy areas.
  • A positive can-do attitude.
  • Ability to work independently and pro-actively lead a project team.
  • Line management experience.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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