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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. Provides support for business development activities and client acquisition as needed. Acts as regulatory lead and contact person for SFL Pharma GmbH and SFL Pharmaceuticals Deutschland GmbH.
What we do
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
* Learn more about our core values here!
What we offer
* The estimated hiring range for this role is € 125k- 155K plus applicable bonus. 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.
* Benefits vary by location and may include:Remote workingFlexible time offPaid holidaysMedical insuranceTuition reimbursementRetirement plans
What we look for
* Master’s degree in science, toxicology, pharmacology, engineering or related field; Ph.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.
* Direct experience creating and implementing the strategic direction of a company or business unit.
* Excellent understanding of regulatory procedures and guidelines, such Pediatric Investigation Plans, Orphan Drug Designations, Scientific Advice, Marketing Authorization Applications for the EU, UK and CH. Additional regions a plus.
* Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
* 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.
* Demonstrated ability to lead by example and demonstrated skill for technical and supervisory leadership of staff.
* Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.
* Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
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Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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