Regulatory Affairs - CMC
Regulatory Affairs - CMC
Green Key Resources
United States
See who Green Key Resources has hired for this role
Summary
The Regulatory Affairs - CMC (Chemistry, Manufacturing, and Controls) professional plays a crucial role in ensuring that pharmaceutical products meet the necessary regulatory standards and are safe, effective, and of high quality. Their expertise contributes to the development and approval of pharmaceutical products.
Responsibilities
The Regulatory Affairs - CMC (Chemistry, Manufacturing, and Controls) professional plays a crucial role in ensuring that pharmaceutical products meet the necessary regulatory standards and are safe, effective, and of high quality. Their expertise contributes to the development and approval of pharmaceutical products.
Responsibilities
- Develop and execute regulatory strategies for Chemistry, Manufacturing, and Controls aspects of drug development and commercialization.
- Prepare and submit regulatory documents and applications for global regulatory submissions, including INDs, NDAs, MAAs, and variations/supplements.
- Review and assess manufacturing and quality control documentation, such as batch records, stability data, analytical methods, and specifications, to ensure compliance with regulatory requirements and industry standards.
- Communicate with other departments to ensure regulatory compliance throughout the manufacturing process.
- Prepare for inspections and audits and present any identified deficiencies.
- Present and provide guidance to internal teams and external stakeholders, while also maintaining proper documentation of regulatory files and submission records.
- Bachelor's or advanced degree in a scientific discipline (e.g., chemistry, pharmacy, pharmaceutical sciences, or related field).
- Proficient knowledge and understanding of regulatory requirements and guidelines related to CMC in the pharmaceutical industry.
- Experience in regulatory affairs with a focus on CMC activities, including regulatory submissions and compliance.
- Familiarity with global regulations and guidelines from regulatory authorities such as the FDA, EMA, and ICH.
- Strong understanding of manufacturing processes, quality control, and analytical techniques relevant to pharmaceutical products.
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Ability to work both independently and collaboratively in a team environment.
- Ability to manage multiple priorities, meet deadlines, and adapt to changing requirements.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Legal -
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Green Key Resources by 2x
See who you knowGet notified about new Regulatory Affairs Specialist jobs in United States.
Sign in to create job alertSimilar jobs
People also viewed
-
Regulatory Affairs Specialist
Regulatory Affairs Specialist
-
International Regulatory Labelling Lead
International Regulatory Labelling Lead
-
Regulatory Affairs Manager
Regulatory Affairs Manager
-
Regulatory Affairs Manager
Regulatory Affairs Manager
-
Senior Manager Regulatory Affairs
Senior Manager Regulatory Affairs
-
Regulatory Affairs Publisher
Regulatory Affairs Publisher
-
Regulatory Research Specialist
Regulatory Research Specialist
-
Regulatory Affairs Manager
Regulatory Affairs Manager
-
Regulatory Affairs Manager
Regulatory Affairs Manager
-
Sr Associate Regulatory Affairs
Sr Associate Regulatory Affairs
Looking for a job?
Visit the Career Advice Hub to see tips on interviewing and resume writing.
View Career Advice Hub