Director of Compliance and Projects

Senior Director Regulatory Affairs : Leads the European Regulatory Affairs team and supports development of team members to become independent and efficient regulatory affairs professionals / consultants. Provides strategic and operational support to Veristat clients for filings and maintenance of healthcare products and supports regulatory decision-making from a strategic point of view; Supervises team performance of European RA team members and ensures deliverables are of high quality and meets the scope of the respective project and applicable regulatory requirements; Acts as line manager for European RA team members and oversees team budgets and team resources. For more than 30 years, Veristat has built a reputation as global experts in clinical development.

760+ Rare Disease Clinical Trials supported

160+ Marketing Applications supported

In 2022 we supported 8 marketing application that received regulatory approval

This hiring range is specific to Europe (Ireland, France, Germany and Spain) and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to : skills and experience, licensure and certifications, education, specific location and dynamic market data.

Remote workingFlexible time offPaid holidaysMedical insuranceTuition reimbursementRetirement plans

Master’s degree in science, toxicology, pharmacology, engineering or related field; D. preferred, with applied training relevant to Regulatory Affairs.

10+ years of experience in Regulatory Affairs at Pharma and CRO / Consultancy level, with a minimum 8 years of supervisory experience required.

Excellent written and oral communication skills including grammatical / technical writing skills, and familiarity with moderately complex study designs and regulatory requirements that apply to Phase I-IV clinical trials, PIPs, ODDs, SA and Marketing Authorization Applications are required.

In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) / consultancy industry with pharmaceutical / biotech companies.

Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.

Senior Director, Regulatory Affairs

• Spain