Regulatory Affairs Manager (Lenoir) Job at EPM Scientific, Lenoir, NC

ZmFnQTI3OEVKMXBxR3Z5bm1qa1B0bGV4Smc9PQ==
  • 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

Part time,

Similar Jobs

Allied Universal®

Security Guard - Hiring Immediately Job at Allied Universal®

 ...questions regarding Equal Employment Opportunity, have difficulty using the online system and require an alternate method to apply, or require an accommodation at any time during the recruitment and/or employment process, please contact our local Human Resources... 

HouseSitter.com

House Sitter Wanted - House Sitter Needed In New York, Ny Earn $250 Daily! Job at HouseSitter.com

Looking for a responsible house sitter in New York, New York! I am seeking someone reliable to take care of my home, pets, and collect mail while I'm away. The duties include pet feeding and ensuring the house remains in good condition. The pay for this daily house sitting... 

JP Morgan Chase & Co.

Product Associate, Global Technical Security Job at JP Morgan Chase & Co.

 ...Product Associate, Global Technical Security at JP Morgan Chase & Co. summary: The Product Associate in Global Technical Security supports product development by collaborating with product managers and cross-functional teams to design security solutions that enhance... 

Strategos Consulting

Systems Security Analyst / Cyber Defense Analyst with Security Clearance Job at Strategos Consulting

 ...the Chief of Naval Operations (CNO) define the future Navy, its missions and roles, support combat readiness, and strengthen maritime security cooperation. Title: Systems Security Analyst / Cyber Defense Analyst Location: Newport, RI Full Time (Y/N): Y Status... 

Summit Recruiting Group

Physician Pediatrics - Competitive Salary Job at Summit Recruiting Group

 ...practice medicine in MT ~1 in 3 light call schedule Compensation/Benefits: ~ Perpetual Salary ~ CME and 30-days PTO ~6-month Paid Housing Option, just a block from the Clinic ~150k in Student Loan Repayment ~ Full benefits package About the Hospital: ~...