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

On Time Staffing

Cherry Picker/Reach Forklift Operator Job at On Time Staffing

 ...duties not driving Clamp truck (housekeeping, stacking, stretch wrapping, etc.) Job Requirements: Must have minimum 1 year of cherry picker, EPJ, and reach forklift experience Must have no recent gap of operating in the last 6 months to qualify. Must be able to... 

The Job Center Staffing

Cherry Picker 7a Job at The Job Center Staffing

Cherry Picker 7a The Job Center Staffing is hiring associates on 1 st shift for a Cherry Picker at UPS in the Hebron, KY area. This is a great opportunity for a temp to hire placement. Compensation/Shift/Benefits of Cherry Picker $1 6.50 7 a- 3:30 p Monday -... 

Hyatt Regency Lost Pines Resort and Spa

Beverage Cart Attendant | Part-time Job at Hyatt Regency Lost Pines Resort and Spa

 ...course, where we pride ourselves on delivering exceptional service and creating memorable experiences for our guests. As a Beverage Cart Attendant, you'll be at the heart of our hospitality, ensuring golfers stay refreshed and energized throughout their game. Key Responsibilities... 

Blackhawk Network

Retail Merchandiser - Gift Cards - Jackson, MS Job at Blackhawk Network

About Blackhawk Network:Interested in working in the gift card industry?We are hiring experienced Merchandisers to work for Blackhawk Network, one of the Worlds Largest Gift Card Companies!Blackhawk Network is one of the worlds largest gift card and payments company... 

PennVeterinary Supply, Inc

Administrative Assistant Job at PennVeterinary Supply, Inc

 ...and meet company objectives. Candidates must be available to work a hybrid schedule from 8:00am to 5:00pm, Monday through Friday....  ...in an office setting a plus Ability to work from a dedicated home office with highspeed internet (20Mpbs up, 5Mbps down) Ability...