Sr. Manager, Regulatory Affairs

Sr. Manager, Regulatory Affairs
  • Competitive
    HOUR
  • Temporary to Hire
  • Richmond VA, US Richmond RICHMOND CITY US
Job Ref: JO000120109
Sector: Clinical
Sub-sector: Reg & Compliance
Date Added: 12 July 2021


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

#LI-KS1

#Remote

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.

SRGTalent
26/07/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Kayla Sanford

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