Director, Regulatory Affairs

Job summary

The Director of Regulatory Affairs provides strategic and operational consulting for clients, managing interactions with health authorities and the FDA. They are responsible for preparing regulatory documentation such as INDs, NDAs, and BLAs while leading cross-functional teams.

Job details

Job Description: Director, Regulatory Affairs Director Regulatory Affairs, responsible for strategic and operational regulatory consulting for client companies. The Director RA will be client facing and will be responsible amongst others for: Strategic Advice to clients, with focus on early development through to NDA/ BLA Independent preparation of regulatory documentation such as US IND, NDA/BLA modules, ODD, Fast track / other designations, FDA advice requests. Scientific Interaction with internal cross functional teams Client facing & Agency point of contact: Interaction with clients and FDA, lead interactions with Health Authorities Internal BD & marketing facing role Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. 105+ approved therapies for marketing applications prepared by Veristat 480+ oncology projects in the past 5 years 350+ rare disease projects delivered in the past 5 years Flexible, inclusive culture — 70% remote workforce, 66% women-led teams Learn more about our core values here! What we offer - The estimated hiring range for this role is $195K-223K plus applicable bonus. This hiring range is specific to the US 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 working Flexible time off Paid holidays Medical insurance Tuition reimbursement Retirement plans What we look for Bachelor’s degree in science, toxicology, pharmacology, engineering or related field; Advanced Scientific degree such as Master’s degree, Ph.D. or Pharm.D. preferred, with applied training relevant to clinical trials. 10 years of relevant experience working directly for a CRO/ Pharmaceutical Company, with a minimum 5 years of experience leading regulatory development projects. 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 and technical writing skills, and familiarity with moderately complex study designs and regulatory requirements that apply to Phase I-IV clinical trials are required. In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies. Demonstrated ability to lead by example with 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. Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

What you’ll do

The Director of Regulatory Affairs provides strategic and operational consulting for clients, managing interactions with health authorities and the FDA. They are responsible for preparing regulatory documentation such as INDs, NDAs, and BLAs while leading cross-functional teams.

Requirements

Candidates must hold a Bachelor's degree in a scientific field, with an advanced degree preferred, and possess at least 10 years of relevant experience. A minimum of 5 years of experience leading regulatory development projects and thorough knowledge of ICH GCP guidelines are required.

Benefits

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

Listed skills

• Documentation · Preferred
• Health · Preferred
• Client · Preferred
• Development · Preferred
• Flexible · Preferred
• Communication · Preferred
• Google Cloud · Preferred
• Microsoft · Preferred
• Microsoft Excel · Preferred
• Microsoft Word · Preferred
• Teams · Preferred
• Technical · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory affairs
• Strategic consulting
• NDA/BLA preparation
• FDA interaction
• Clinical trials
• ICH GCP guidelines
• Technical writing
• Project leadership
• Scientific communication
• Regulatory strategy
• Cross-functional team leadership
• Medical terminology
• Regulatory documentation
• Drug development
• CRO industry knowledge
• Regulatory Affairs
• Regulatory Documents
• Organizational Skills
• Microsoft Word
• Microsoft Excel
• Research
• Biotechnology
• Biologics License Applications (BLA)
• Clinical Research
• Clinical Trials
• Consulting
• Leadership
• Marketing
• Good Clinical Practices (GCP)
• Interpersonal Communications
• Oncology
• Medical Terminology
• Non-Disclosure Agreement (Intellectual Property Law)
• Pharmaceuticals
• Pharmacology
• Technical Writing
• Toxicology
• Verbal Communication Skills

Job areas

• Healthcare
• Science & Research
• Consulting
• Management & Leadership
• Director of Regulatory Affairs
• Regulatory Affairs Manager
• Legal Professionals Not Elsewhere Classified
• Regulatory Affairs Managers
• Managers, All Other

More jobs from Veristat