International Staffing Consultants, Inc.
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Corporate Head of Regulatory Affairs

Location: Barcelona or remote but open to commute.

Job Purpose 

Ensure that the worldwide regulatory strategies are clearly supported and implemented in the product development, commercialization and life cycle management of the medicinal products.

Major Accountabilities 

Development of international regulatory strategies and timelines for projects to ensure that various pathways are examined early in the process. 

  • Lead interaction with Regulatory Agencies (EMA and local Authorities)
  • Lead Regulatory strategy for new developments / pipeline. Generics, Valued Add Medicines, Innovative and orphan drugs.
  • Communicate the RA strategies, processes and company goals to the cross-countries RA teams and each key functional area.
  • Direction and contribution to the preparation and submission of domestic and international regulatory filings in compliance with the current guidelines and procedures established by regulatory agencies.
  • Establishing of regulatory priorities and budgets and allocating resources.
  • Performance of RA related due diligence assessments. 

Specific Accountabilities 

  • Making decisions and solving problems by analyzing information and evaluating results to choose a solution in compliance with the strategic goals of the company.
  • Developing constructive and cooperative working relationships within the company by development of specific goals and plans to prioritize the work of the employees.
  • Number of team associates: DIRECT: 5-10 INDIRECT: 20-25

 

Professional Experience

Minimum Experience

Minimum of 15 years of relevant experience in Regulatory roles with proven experience in Branded and Generics business. Extensive experience interacting with regulators, specifically with the EMA, MHRA (UK) and Swiss Agency

 

Ideal Experience

  • Minimum of 15 years of relevant experience as “Regulatory Affairs” with international orientation in a globally operating pharmaceutical company.
  • Proven ability to lead and influence strategy planning and implementation.
  • Proactive and strategic thinking with strong decision-making skills.
  • Proven ability to work effectively across a matrix organization with multiple stakeholders, with the ability and strength to focus a team to work towards its goals.
 
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