The Senior Manager, Regulatory Affairs will support regulatory activities for the Vaccine Business Unit as the regulatory representative on assigned Product Team(s). He/she will work with functional line management and team members across multiple disciplines including nonclinical, clinical and CMC to develop regulatory strategies and manage regulatory submission activities. The Sr. Manager will take the lead on regulatory activities, including the management of authoring, review, and coordination of submissions, as well as leading, planning and executing meetings with regulatory agencies. He/she will have supervisory responsibilities.
* Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory strategy and plans to gain alignment with team members, line management, and multiple stakeholders, including funding agencies
* Develop innovative regulatory strategies that incorporates risk identification and mitigation
* Lead the preparation, planning and execution of aligned regulatory strategy through timely regulatory submissions
* Oversee development of submission content, documents and timelines
* Provide critical review of all documentation supporting regulatory applications, provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management
* Lead meetings both in-person and teleconferences with regulatory agencies for specific projects
* Negotiate complex issues with regulatory agencies and prepare responses to questions and comments from regulatory agencies
* Ensure regulatory product compliance for assigned products (e.g. agency commitments)
* As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance
* Maintain awareness of new and developing legislation, policy and technical regulatory guidance relating to assigned programs. Interpret existing regulations and guidance documents for regulatory department and/or project teams. Conduct and analyze regulatory research to understand competitor activity
* Interact with company partners and consultants for various regulatory matters as needed
* As required, develop procedures to support the regulatory affairs department
* May provide input to business unit strategies from regulatory perspective
* Will be responsible for a functional area and/or have direct reports
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.