The Director, Regulatory Affairs will lead development of regulatory strategy, build processes to ensure global regulatory compliance, and manage all regulatory submissions and interactions. The Director will prepare for meetings, teleconferences, and other communications with FDA and other regulatory agencies, educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process.
Lead the development of global regulatory strategy, ensuring that programs meet quality and safety standards required by patients, health care providers, and regulatory agencies.
Coordinate and balance priorities of various stakeholders (corporate, scientific, clinical) in the context of regulatory requirements, through active participation in Product Development Teams.
Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices.
Provide critical review of all documentation supporting regulatory applications, including organization of regulatory file rooms and document signatures.
Lead the preparation and submission of regulatory submissions to FDA and other regulatory agencies.
Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
Monitor applicable current and new regulatory requirements.
Review and update regulatory processes and documentation practices to ensure company is in compliance and audit ready.
Interact with company partners and consultants on regulatory matters.
Contribute to the regulatory perspective on government proposals and external due diligence activities.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any 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 accommodation@aerotek .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.