Job Title: Corporate Head of Regulatory Affairs

Location: Europe (travel to the Barcelona often)

Salary: Basic salary + Bonus + Social Benefits + Investment Plan

Our client is looking for a Corporate Head of Regulatory Affairs with experience of working with innovative drugs.

Responsibilities:

• 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.  
• 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.
• Direct reports (5-10) and Indirect reports (20 – 25)

Requirements:

• Relevant experience as “Regulatory Affairs” with international orientation in a globally operating pharmaceutical company.
• Extensive experience interacting with regulators, specifically with the EMA, MHRA (UK) and Swiss Agency
• 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.