Director, Regulatory Affairs

Responsibilities

• Strategic Advice to clients, with focus on early development through to NDA/BLANon-mandatory 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

Qualifications

• 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.

Pay

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

Benefits vary by location and may include:

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