SRG is a Global Life Sciences staffing and consulting firm and we are looking for a Sr. Manager of Regulatory Affairs for our client in Richmond, VA. This can be a remote position for the right candidate!
As Senior Manager, Regulatory Affairs, you will:
- Lead, manage, and develop Regulatory Affairs team members.
- Develop and implement regulatory strategies for programs in all phases of development. Conduct program meetings to assign and manage plans, roles, responsibilities, and timelines.
- Lead Regulatory Affairs team efforts in drafting and submitting dossiers in the United States and Canada, including CMC, nonclinical, clinical, human factors, and pharmacovigilance activities.
- Establish and ensure adherence to timelines for regulatory submissions.
- Lead interactions with personnel at regulatory agencies, partner companies, and vendors; lead meetings and presentations with regulatory agency reviewers and inspectors.
- Stay abreast of new regulatory requirements and interpret existing requirements as they relate to our products, procedures, testing, and records keeping; communicate related requirements to team members.
- Review and approve design and manufacturing changes, nonconforming materials reports, rework orders, test protocols, and reports to ensure compliance with
- Act as product subject matter expert for labeling, product claims, training materials, publications, press releases or marketing programs in collaboration with our compliance team.
- Ensure periodic reports (e.g., Annual Reports, Periodic Safety Reports) are submitted to regulatory dossiers on time.
- Ensure Transfer of Regulatory Obligation Agreements are in place with development
- Ensure Regulatory Standard Operating Procedures are in place to facilitate compliance with
- Advise on international product registration and export approval requirements.
- Recruit, retain and develop regulatory team members, contractors and consultants to meet organizational needs.
A successful Senior Manager, Regulatory Affairs will have:
- Impeccable attention to detail and commitment to flawless execution of regulatory submissions and other critical work product.
- Demonstrated leadership skills, including the ability to think strategically, excellent interpersonal communication, and the desire and ability to develop and motivate early-career professionals.
- The proven ability to excel in a fast-paced environment and manage competing priorities.
- A demonstrated results- and outcome-oriented approach to work.
- Strong analytical skills, with the ability to evaluate technical data, review reports, and synthesize information in view of regulatory requirements.
- The ability to confidently communicate complex information to broad internal stakeholders and external partners.
- A strong intellectual curiosity and desire to be part of an innovative organization.
- A commitment to inclusivity at the team and organization level.
To be considered for the position, you must have:
- Bachelor’s degree in a scientific discipline.
- At least 8 years of increasingly responsible experience in the pharmaceutical, biotechnology, and/or or medical device industries.
- Direct experience with pharmaceutical regulatory submissions, including electronic submissions in the United States and Canada.
- A proven track record of effective collaboration with regulatory agencies, including the Food & Drug Administration.
- At least 2 years of experience leading and managing a team.
- For a remote hire, the ability to travel to Richmond, Virginia on a monthly basis or as needed.
Additional preferred qualifications:
Regulatory Affairs Certification preferred
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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