Leads strategic and operational regulatory consulting for pharmaceutical and biotech clients from early development through NDA/BLA. Prepares IND, NDA/BLA, orphan drug designation, fast-track, and FDA advice-request documentation; advises clients and internal teams; serves as a client and Health Authority liaison; leads FDA interactions; and supports business development and marketing. Provides technical and supervisory leadership while applying knowledge of ICH GCP, clinical trials, regulatory requirements, and CRO-pharmaceutical relationships.
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.
Similar Jobs
29 Days Ago
Healthtech • Biotech • Pharmaceutical
Lead the Canadian Regulatory Affairs group to develop and execute regulatory strategy, ensure compliant submissions and labelling, manage Health Canada interactions, maintain regulatory compliance and inspection readiness, oversee regulatory quality and third parties, support product launches, and mentor a cross‑functional, bilingual team.
.png)
eCommerce • Fintech • Hardware • Payments • Software • Financial Services
Develop and manage Square’s always-on B2B content engine across social, thought leadership, customer stories, partner content, and industry narratives. Build content calendars, formats, briefs, campaigns, and AI-assisted workflows; coordinate cross-functional teams and external partners; oversee production through launch; and analyze performance to optimize messaging, formats, and distribution.
Top Skills:
Ai ToolsLinkedInSocial AnalyticsSocial Media Platforms
Blockchain • eCommerce • Fintech • Payments • Software • Financial Services • Cryptocurrency
Develop and manage Square’s always-on B2B content engine across social, thought leadership, customer stories, partner content, and industry narratives. Build content calendars, formats, briefs, campaigns, and AI-assisted workflows; collaborate with marketing, sales, creative, communications, and external partners; manage production through launch; and use performance insights to optimize content and distribution.
Top Skills:
Ai ToolsLinkedInSocial Media Platforms
What you need to know about the Vancouver Tech Scene
Raincouver, Vancity, The Big Smoke — Vancouver is known by many names, and in recent years, it has gained a reputation as a growing hub for both tech and sustainability. Renowned for its natural beauty, the city has become a magnet for professionals eager to create environmental solutions, and with an emphasis on clean technology, renewable energy and environmental innovation, it's attracted companies across various industries, all working toward a shared goal: advancing clean technology.
