Associate Director of Regulatory Affairs - Permanent - Onsite
Proclinical Staffing is seeking an Associate Director of Regulatory Affairs to join a top medical program. This is a permanent role located in Philadelphia, PA.
Primary Responsibilities
This position is responsible for leading the development, review, and execution of regulatory strategy and operations for drugs and devices throughout the product lifecycle with a focus on early development. The Associate Director (AD) will join a dynamic leadership team that collaboratively supports all aspects of early-stage and expanded use product development including nonclinical, quality, and clinical expertise.
The Associate Director of Regulatory Affairs will:
- Consult with faculty and staff on product development and regulatory related topics with a nonclinical focus
- Ensure research projects are conducted in compliance with federal, state, local and policies
- Ensure unit activities are high quality, appropriately resourced, and in alignment with the leadership teams strategic standards and goals
- Conduct quality review of all submissions, reports, core documents, and other key sponsor materials for all projects
- Ensure proper guidance, exemption determinations and sponsor qualification and training is provided
- Risk mitigation and escalation when needed.
- Establish and maintain best practices and PSOM policy and procedures (SOPs)
- Use and establish best practices for electronic submissions and document management systems
- Track and report on assigned unit metrics.
- Maintain current regulatory knowledge and evaluate implications on unit activity and processes/procedures
- Function as a regulatory representative in discussions with Health Authorities.
- Monitor national and international requirements through Health Authority news announcements, reviews of publications, seminars, and direct communication with outside regulatory personnel.
- Prepare and submit reports to senior management, as required.
- Strategy and Development:
- Develop and implement strategies for the earliest possible approval of regulatory submissions
- Responsible for the planning and direction of regulatory affairs activities
- Leadership and Management:
- Provide leadership and management of the Regulatory Affairs function
- Supervision and Mentoring Staff
- HA Submissions:
- Author (when applicable), review, submit, and maintain IND, IDE, and CTA applications, safety reports, amendments, and annual reports in accordance with established SOPs, timelines, and submission dates.
- Prepare and document responses to inquiries from Regulatory Authorities.
- Prepare and submit regulatory applications and reports.
- Coordinate with cross-functional groups on the content, review, and assembly of regulatory documentation
- TMF Administrator and Core Sponsor Team Member:
- Review clinical protocols, core documents, data, and reports to ensure clarity, consistency, and conformance to regulations, guidelines and regulatory strategy as well as suitability for submission to regulatory agencies.
- Maintain TMF in inspection ready form and educate/train sponsor team members as needed
- HA and Vendor Liaison:
- Function as a contact with Health Authorities
- Interact with regulatory agencies on product-related regulatory issues.
- Schedule, participate in, and prepare briefing documents and reports for meetings with Health Authorities and Collaborators.
- Negotiate to resolve key regulatory issues.
- Qualify and ensure appropriate vendor oversight
- Subject Matter Expert (SME):
- Project Manager for assigned projects
- Subject matter expert for the SSU on assigned regulatory related subject matter
- Perform additional duties as assigned
If you are having difficulty in applying or if you have any questions, please contact Natalie Magola at (+1) 267-523-2553 or n.magola@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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