Regulatory Affairs Manager

Location

Rockville, MD | United States

Job description

 
Title: Regulatory Affairs Manager
Location: Remote
Type: Permanent
Salary: 120K – 140K plus 10-20% discretionary bonus
 

Requirements

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• Minimum of 3-5 years of experience in operational regulatory affairs within the biotech, preferably in oncology.
• Writing Canadian and US submissions (BGTD experience)
• eCTD experience required (package used is off the shelf product)
• Strong knowledge of global regulatory requirements and guidelines for drug development.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Proven ability to manage multiple projects simultaneously and meet tight deadlines.
• Detail-oriented with a strategic mindset and problem-solving skills.

• Develop and implement regulatory strategies to support the development and commercialization of oncology products.
• Prepare and submit regulatory submissions to health authorities, including INDs, CTAs, NDAs, and marketing applications.
• Coordinate and liaise with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
• Keep abreast of regulatory changes and updates relevant to the oncology industry, providing guidance to internal stakeholders.
• Represent the company in interactions with regulatory agencies and support regulatory inspections and audits.
• Manage regulatory documentation and maintain compliance with applicable regulations and standards.
  
  

Job tags

Salary