CMC Regulatory Affairs Manager Job at cGxPServe, Tarrytown, NY

aGlBZVRsWlBvSDB3cTRWRy9HL1VIb1lP
  • cGxPServe
  • Tarrytown, NY

Job Description

Responsibilities:

  • Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines.
  • Provide regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including manufacturing process development, technology transfer, scale-up, validation, and post-approval changes.
  • Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal stakeholders, ensuring alignment with global regulatory strategies and objectives.
  • Proactively identify regulatory risks, opportunities, and challenges related to CMC activities and provide strategic recommendations to mitigate risks and optimize regulatory outcomes.
  • Collaborate with internal stakeholders, including Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Clinical Development, to ensure regulatory compliance and alignment with business objectives.
  • Establish and maintain positive relationships with regulatory agencies and industry peers, representing the company in regulatory interactions, meetings, and negotiations as needed.
  • Stay abreast of emerging regulatory trends, changes, and developments related to CMC and communicate potential impacts to relevant stakeholders.

Requirements:

  • Bachelor's, Master's, or Ph.D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline.
  • 5-7 years of experience in regulatory affairs CMC in the pharmaceutical industry.
  • Demonstrated expertise in preparing CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (e.g., FDA, EMA, Health Canada, PMDA).
  • Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e.g., ICH guidelines, FDA regulations, EudraLex).
  • Excellent communication, collaboration, and project management skills, with the ability to effectively interact with cross-functional teams and external stakeholders.
  • Proven ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced, dynamic environment.
  • Detail-oriented mindset with a focus on quality, accuracy, and compliance.
  • Experience with regulatory submissions for small molecules, biologics, or other pharmaceutical modalities is preferred.
  • Regulatory Affairs Certification (RAC) is a plus.

Job Tags

Similar Jobs

Personnel Response Team

Construction Laborer Job at Personnel Response Team

 ...REQUIRED General laborers for School remodel needed for construction in the Largo area. No experience is necessary for these positions. We have immediate...  ...clean and free of dust and debris . Must be able to work alone and complete set task . Must have work boots other... 

Hyatt Place East Moline Quad Cities

Breakfast Cook Job at Hyatt Place East Moline Quad Cities

Job Summary: Part-time, $15/hr, Friday Saturday & Sunday 5am-11am. A Cook is responsible for preparing all food items based on standardized recipes for the Complimentary Breakfast Area while maintaining the highest standards to produce an appealing and appetizing... 

Chicago Protective Apparel

Pattern Maker/Sample Maker Job at Chicago Protective Apparel

 ...welding, glass handling, chemical & petroleum, and maintenance industries. What We Do At MWCPA, we are building a world where Safety is foundational, Performance is enhanced, and Trust in the brand is unshakable. We create and elevate protection beyond your... 

North Pointe Strategies

Digital Sales & Marketing Consultant Job at North Pointe Strategies

Are you ready for your next sales adventure?Digital Sales & Marketing Consultant on a 1099 contract basis. Whether you're an experienced sales professional...  ...new to the field, this role offers the flexibility of remote work and the opportunity for substantial earnings with... 

WestRock

Maintenance Electrician Job at WestRock

 ...technology to move fiber-based packaging forward. Electrical, Maintenance Specialist Description & Requirements The...  ...jobs quickly. How you will impact WestRock: As an Electrician you will (among other things): ~ Work from prints,...