Regulatory Affairs Project Manager Job at Infotree Global Solutions, Foster, CA

cDU0Y1BDNkJ4VC9Uc0psSml5enRxaTE2blE9PQ==
  • Infotree Global Solutions
  • Foster, CA

Job Description

Job Summary

We are seeking a highly motivated and experienced Regulatory Project Manager to join our team within the Pharmaceutical industry. The ideal candidate will have a deep understanding of regulatory affairs, drug development, and product registration processes, with a strong focus on biologics, including monoclonal antibodies, gene therapies, vaccines, and biosimilars. This individual will be responsible for managing the regulatory strategy, submission process, and overall project lifecycle to ensure compliance with all relevant regulations, as well as maintaining communication with health authorities globally.

Key Responsibilities:

  • Develop, implement, and manage regulatory strategies for biologics products, ensuring alignment with company objectives and regulatory requirements.
  • Provide expert advice on regulatory pathways, including IND, BLA, and CTA submissions.
  • Ensure timely preparation and submission of regulatory documents to Health Authorities (FDA, EMA, ICH, etc.).
  • Coordinate with internal departments (clinical, CMC, quality, manufacturing) to support regulatory submissions and compliance.
  • Manage the preparation, compilation, and submission of regulatory dossiers, including INDs, BLAs, MAA, and global submissions.
  • Stay up-to-date with evolving regulatory requirements for biologics in key markets (US, EU, Japan, etc.).
  • Ensure product compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other applicable regulations.

Qualifications:

  • Bachelor’s degree in Life Sciences, Pharmacy, or related field (Master’s or PhD preferred).
  • Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on biologics.
  • Proven track record of managing regulatory submissions for biologics products, including INDs, BLAs, and international filings.
  • Strong understanding of the biologics development process and global regulatory requirements (FDA, EMA, ICH, etc.).
  • Experience with both preclinical and clinical regulatory activities, including CMC, clinical trial applications, and post-market submissions.
  • Excellent project management skills, with the ability to manage multiple projects simultaneously.
  • Proficient in regulatory submission management tools and project management software.
  • Experience with biologic product lifecycle management, including commercialization.

Job Tags

Similar Jobs

PIH Health Careers

Monitor Tech/Unitclk, Emergency, Full time, 7am - 7pm Job at PIH Health Careers

 ...Emergency Department: Provides cardiac monitoring and clerking duties under the direction/supervision of the licensed nurse. Performs...  ...Hospital, PIH Health Whittier Hospital, 37 outpatient medical office buildings, a multispecialty medical (physician) group,... 

PRI Technology

Director, Internal Audit, Liquidity Risk Management and Interest Rate Risk Job at PRI Technology

 ...the design and execution of the Banks Finance and Corporate Treasury (Interest Rate Risk, Liquidity Risk Management and Funds Transfer Pricing) practices established through Combined U.S. Operations Finance and Treasury internal infrastructure, frameworks, policies,... 

Spectrum

Senior, Contract Administrator, Spectrum Enterprise Job at Spectrum

 ...repository? As a Senior Enterprise Contracts Administrator at Spectrum Enterprise, you can do that. Spectrum Enterprise provides...  ...travel as needed. HOW YOU CAN MAKE A DIFFERENCE: Support sales teams and operating units in all aspects of contractual issues... 

Aerotek

Light Industrial Assemblers Job at Aerotek

**Job Title: Light Industrial Assemblers****Job Description** Now hiring production technicians for a local manufacturing company. Duties include basic assembly, lifting up to 30 lbs, and other production line duties. These are long-term and permanent positions with... 

JCW

Senior Commercial Loan Officer Job at JCW

 ...metro market. In this role, you'd be sourcing Commercial deals $500K+ in size while stepping into a mentorship position for junior Loan Officers. This position provides strong compensation marks, as well as a positive work/life balance and competitive benefits. Please...