Job Summary
The Regulatory Affairs Specialist is responsible for ensuring compliance with applicable regulations and guidelines in the development and marketing of products. This role serves as a vital link between the organization and regulatory agencies, assisting in the preparation and submission of documentation required for regulatory approval.
Responsibilities
- Coordinate regulatory submissions, including INDs, NDAs, and other necessary documents for product approval.
- Monitor regulatory developments and updates pertaining to industry standards and practices.
- Collaborate with cross-functional teams to ensure compliance in product development from concept through to post-market activities.
- Prepare and maintain regulatory files and relevant documentation as mandated by regulatory authorities.
- Advise internal teams on regulatory strategy and the impact of regulations on business operations.
Qualifications
- Bachelor’s degree in a relevant field such as life sciences, pharmacology, or a related discipline.
- A minimum of 2 years’ experience in regulatory affairs within the pharmaceutical or biotech industry.
- Strong knowledge of regulatory requirements and processes for product submissions.
- Excellent communication skills and the ability to present complex information clearly.
- Detail-oriented with effective organizational skills to manage multiple projects.
Location
Work Arrangement
Remote
Hunter Recruiting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
