The Associate Director plays a crucial role at Company as a key member of the Regulatory Affairs department, reporting to the Vice President of Regulatory Affairs. The successful candidate will be a key participant in the formulation of regulatory strategy and will be responsible for day to day activities including promotional materials review, regulatory submissions coordination, interaction with US authorities, and collaboration with international affiliates.
The company currently markets a diverse line of prescription human drugs, medical devices and dietary supplements focused in both the Female related Health and Dermatology fields. Our vision for growth is supported by a strong pipeline and dynamic team.
The successful candidate should have a demonstrated command of US Drug Regulatory Affairs, with a firm understanding of medical devices and/or dietary supplements. In addition, it is important to have excellent communications and presentations skills, and the ability to work collaboratively with external and internal partners.
- Provide strategic regulatory guidance and oversight to Medical Affairs, Marketing, Sales, Quality, and Operations.
- Provide guidance on regulatory matters involving labeling, advertising, and other public communications.
- Contribute to the development and implementation of corporate and departmental strategies and procedures to ensure efficient and compliant practices.
- Perform review of manufacturing, quality, and commercial documents providing facilitative commentary and feedback, and assuming responsibility for regulatory approval as appropriate.
- Coordinate submission of necessary documentation to ensure compliance and maintain regulatory documents and registration in compliance throughout the marketing territory.
- Prepare Chemistry, Manufacturing and Control (CMC) using eCTD format, familiar with eCTD submission, and submit to FDA in a timely submissions (annual reports, amendments, notifications, briefing packages, 510(k), safety reports, and product registrations).
- Prepare labeling submission (SPL file) and update labeling registration for the company.
- Provide support to marketing for the promotional labeling as needed.
- Monitor trends and changes in regulations and advise internal stake holders on potential impact on current and future activities.
- Advise senior management on prospective product and business acquisitions to provide regulatory requirements and timelines, as needed.
- Support new product development through participation in project team meetings and providing regulatory guidance and fostering solutions to best meet these requirements.
- Foster collaborative and effective working relationships with FDA and State Authorities to establish and maintain cordial relationships.
Skills and Experience
- Minimum of baccalaureate in a life science or health science discipline. Advanced degree preferred. Professional certification preferred. (e.g. RAC)
- Minimum of 5 years of US Regulatory Affairs experience, including post marketing activities, with primary focus in prescription drugs.
- Experience in medical device and/or dietary supplement regulatory requirements is a plus.
- Demonstrated expertise in US regulatory requirements; ability to interpret and apply regulations (FDA, ICH, and other) to specific projects. Knowledge of global requirements.
- Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success.
- Excellent verbal and written communications skills.
- Proficiency in computer applications such as Word, Excel, and PowerPoint.
Our people are everything. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With over 230 non-franchised offices, Aerotek serves 17,000 clients and 300,000 contract employees every year. To learn more, visit aerotek.com.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information or any other characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email [email protected] .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.