Wake Forest Baptist Health Job - 31148039 | CareerArc
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Company: Wake Forest Baptist Health
Location: Winston-Salem, NC
Career Level: Director
Industries: Healthcare, Pharmaceutical, Biotech

Description

JOB SUMMARY:

This position is responsible for the CMC Regulatory Affairs, which includes providing strategic and operational leadership in the development and execution of the CMC.

This position will support the expanding pipeline of products in development and manufacturing from a regulatory perspective. The successful candidate will provide leadership and work closely within The Regenerative Medicine Clinical Center and other areas within the Institute. This includes the development and implementation of regulatory strategy, ensuring timely preparation for the CMC Section of an IND, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements.

The successful candidate will serve as a resource to team members for the regulatory requirements to conduct manufacturing and testing activities for regenerative medicine products and have a minimum of 3 years' experience with FDA in an applicable role.

The successful candidate will be responsible for driving the CMC regulatory strategies and the preparation and submission of a high-quality CMC section of IND in close collaboration with our in-house RMCC Process/Product Development, Manufacturing and Quality Teams, Faculty, and Collaborators.



EDUCATION/EXPERIENCE:

  • Graduate degree required, PhD preferred
  • RAPS/ RAC desirable
  • 15+ years' experience leading Regulatory Affairs within industry with 5 years of specific leadership and management experience and 3 years' experience in FDA associated with CMC review.

  • Experience leading the Regulatory Affairs specifically the designing, writing, and submission of regulatory filings and correspondence within a similarly complex product.

#LI-CTB

*TMJ



ESSENTIAL FUNCTIONS:

Regulatory Affairs -

  • Work closely with the leadership team, lead the development of regulatory strategies and objectives that result in the successful Development and Manufacturing of products in clinical trials or regulated under 21CFR 1271. Consideration for Design Control and compliance to 21 CFR 820.
  • Serve as regulatory agency contact {with the FDA and at other agencies) to achieve regulatory objectives for CMC, by fostering strong relationships and acting as a credible, reputable and effective advocate for RMCC and WFIRM.
  • Serve as key point of contact in relation to managing and directing regulatory inspections.
  • Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future products and provide strategic and tactical direction to drive efficiency and safety in the regulatory approach.
  • Develop and design robust regulatory structure, processes and procedures and budget forecasting based on expert understanding and insight of future regulatory policy.
  • Partner with and support product/process development and CMC including the review and submission of manufacturing in clinical protocols and regulatory documents, publications throughout the product life cycle.
  • Direct long- and short-term CMC regulatory planning including structure, training, and systems requirements.


SKILLS/QUALIFICATIONS:

  • Strong leadership competencies and strategic business perspectives required, to ensure that sound product development, regulatory and compliance practices are followed.
  • In-depth understanding of the development and life cycle management process for Regenerative Medicine Products including Biologics, Drugs, Devices and Combination Products.
  • Expertise in Quality and Compliance as well as experience in managing and preparing for regulatory inspections.
  • Proven interpersonal and influencing skills. This includes a demonstrated ability to use an open and supportive communication style and to work cross functionally with multiple teams.
  • Excellent oral and written communications skills.
  • Commitment to achieving institutional mission while maintaining the highest ethical, regulatory and scientific standards.
  • An entrepreneurial, innovative, energetic, hands-on, team oriented attitude and approach.
  • The ability to think strategically as well as execute project details.




WORK ENVIRONMENT:

Clean, comfortable, office environment



To apply for this position, please click on the "Apply Now" button on this page. You must complete the application process and then submit your application by clicking on the "Submit" button located at the bottom of the page titled "Submit Online Application". You will receive the following message once you hit the submit button: "You have successfully submitted your job application".

Computers are available for applying within the lobby of the Human Resources Department located at 1920 West First Street, (on the corner of Miller and First Street) Winston-Salem, North Carolina 27104. You may also call our office for assistance at (336) 716-6464. Office hours are Monday-Friday, 8:00am-5:00pm.

If you are an individual with a disability and need reasonable accommodation to participate in the application process, please contact our Supervisor of Office Services by phone (336) 716-3367 or email at accommodationrequest@wakehealth.edu.

It is the policy of Wake Forest Baptist Medical Center to administer all educational and employment activities without discrimination because of race, sex, age, religion, national origin, disability, sexual orientation, gender identity or veteran status (except where sex is a bona fide occupational qualification or a statutory requirement) in accordance with all local, state, national laws, executive orders, regulations, and guidelines.


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