Job Listing
AD/Director of Regulatory Affairs
Job Type
Permanent
Employment
Full Time
Actively searching for an experienced AD/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
