Director of Regulatory Affairs

The Director of Regulatory Affairs will be responsible for the coordination, compilation and submission of biologics and medical device applications in addition other various submissions to regulatory agencies. This person will be responsible for developing and implementing Chemical and Manufacturing Controls (CMC). This role will also provide guidance to project teams on the current regulatory framework from the Food and Drug Administration (FDA) to ensure the added value to the business from the commercialization of medical products. The Director of Regulatory Affairs will be responsible for managing supplier and distributor qualifications and the company’s auditing program as well as maintaining voluntary accreditations, state licenses and establishment registrations and listings.

Duties and responsibilities

1. Provide regulatory guidance to Marketing and the management team on requirements related to advertising, promotion, labeling, corporate and public communications and materials.

2. Manage supplier and distributor qualifications and the organization’s internal and external auditing program.

3. Work with multidisciplinary teams on the commercialization to ensure compliance with FDA regulations including:

a. Coordination, compilation, and submission of regulatory filings including but not limited to: Requests for Designation (RFD), Investigational New Drug (IND), Biologics License Application (BLA), 510(k), and Pre-Market Approval (PMA).

b. CMC development and implementation

c. Support of clinical trial protocol development 

4. Oversee and maintain licensing, registration, and accreditation with the different state, federal, and independent regulatory bodies. 

5. Support and maintain regulatory reporting endeavors including but not limited to MedWatch and Biological Product Deviations.

6. Remains current trends in industry and practices up to and including association memberships with committee or work group participation. Identifies patterns to improve processes. Assists in the development and improvement of policies and procedures for all aspects of business, to include data collection and regulatory compliance.

7. Performs other related duties as assigned.

Qualifications

Education Required: Bachelor of Science or Arts in a relevant discipline is required. 

Experience: Minimum of 7 years Tissue Bank, Medical Device, Biologics or Pharmaceutical experience with 4 years management experience preferred.

Licenses/Certifications: AATB CTBS, ASQ, or other allied health licensure or certification preferred.

Working conditions

Office, processing plant work, travel by air, train, & car. Some evening and weekend work required to ensure company commitments and goals are met. 

Physical requirements

While performing the duties of this job, the employee is regularly required to sit; stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Direct reports

Regulatory Affairs Manager, Audit Program Supervisor

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time. 

Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training.

Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.