Job Listing
Executive Director of Regulatory Affairs
Job Type
Permanent
Employment
Full Time
Actively searching for an experienced Executive Director of Regulatory Affairs to work onsite for an opportunity paying up to $250,000 with a 15% bonus, based on experience. This role involves developing and implementing regulatory strategies aligned with the company’s objectives and regulatory guidelines.
Job Responsibilities
- Develop and execute regulatory strategies in line with company goals
- Oversee regulatory affairs operations ensuring regulatory compliance
- Collaborate with product development teams, regulatory affairs associates, quality assurance associates, and executives
- Regularly update the company’s regulatory plan
- Lead the creation of strategies for FDA device and drug submissions, including INDs, Controlled Correspondence, meetings, and NDAs
- Support company affiliates in regulatory affairs areas such as EMA and ANVISA submissions, and FDA audits
- Contract with external advisors for input on regulatory affairs issues as needed
- Ensure compliance with company procedures and regulatory commitments
- Manage regulatory affairs budget
- Perform other duties as assigned by management
Qualifications
- Minimum of 10 years of US regulatory affairs experience with both drug and medical devices, preferably with generic drug regulatory affairs
- Bachelor’s or Master’s Degree in a biomedical-related field or Regulatory Science
- Professional certification preferred (e.g., RAC)
- Demonstrated experience in writing and managing US regulatory submissions
- Ability to interpret and apply regulations (FDA, ICH, and others) to specific projects
- Demonstrated knowledge and understanding of the drug and device development process
- Supervisory experience required
- Strong collaboration skills with internal and external teams
- Ability to manage regulatory affairs operations and compliance with regulatory directives
