Regulatory Affairs Manager Job at EPM Scientific, Lenoir, NC

R3RidGp1aWVwZ29BWVNUZXR0U2dXR3FSUVE9PQ==
  • EPM Scientific
  • Lenoir, NC

Job Description

Overview:

A growing biopharmaceutical company is seeking a Regulatory Affairs Manager to lead strategic regulatory operations across the U.S., Canada, and other global markets. This is a high-impact leadership role responsible for overseeing regulatory submissions, compliance, and strategy for biologics and medical devices.

Key Responsibilities:

  • Lead preparation and submission of regulatory filings (INDs, BLAs, 510(k)s, etc.) in eCTD format
  • Manage communications with regulatory agencies including FDA, Health Canada, and USDA
  • Oversee promotional and advertising material review and submission
  • Provide regulatory guidance on product development and lifecycle management
  • Collaborate cross-functionally with Quality, R&D, Manufacturing, and Commercial teams
  • Monitor regulatory changes and ensure ongoing compliance
  • Lead and mentor the regulatory team, driving performance and professional growth
  • Support budgeting and resource planning for the regulatory department

Qualifications:

  • 5+ years of regulatory affairs experience in biologics and/or medical devices
  • Strong knowledge of FDA, Health Canada, USDA regulations
  • Experience with eCTD submissions and promotional review
  • Proven leadership and team management experience
  • RAC certification preferred
  • Bachelor's degree in a scientific discipline required

Why Apply?

This is an opportunity to make a direct impact on regulatory strategy and product success within a mission-driven organization focused on improving patient outcomes through innovative immunotherapy solutions.

Job Tags

Similar Jobs

Alisha Alef - State Farm Agent

Intern - State Farm Agent Team Member Job at Alisha Alef - State Farm Agent

 ...Job Description Job Description Position Overview Successful State Farm Agent is seeking a qualified professional to join their winning team for the role of Intern - State Farm Agent Team Member. We seek an energetic professional interested in helping our business... 

Adecco

Manufacturing Assembler Job at Adecco

 ...Job Description Job Description Adecco is seeking Manufacturing Assemblers for exciting roles at AGC Glass in Bellefontaine, OH. This is a great chance to gain valuable experience and grow your career in a dynamic manufacturing environment. Weekly pay starts at $1... 

Floor Coverings International of Waukesha

Carpeting Installer Job at Floor Coverings International of Waukesha

 ...s Largest Property Services Company, FirstService Brands! Flooring installers are the front line of Floor Coverings International, executing our quality and craftsmanship at each job. Our carpeting install teams leave the lasting impression that determines our success... 

ProAmpac

Extrusion Machine Operators & Assistants Job at ProAmpac

 ...wellness program. This is a fantastic opportunity to leverage your manufacturing experience and learn valuable niche skills that are in high...  ...controls and monitors the film production (roll stock of film/plastic) of his or her designated line(s). Oversees the quality, house... 

Arbor Post AcuteBERKELEY

Business Office Manager Job at Arbor Post AcuteBERKELEY

 ...Business Office Manager Position Title: Business Office Manager Department: Administrative Reports to: Executive Director...  ...understanding of senior living billing and payment. Proficient in Microsoft products computer skills. Preferably one year's experience in long...