Executive/ Senior Executive - 21 CFR

Regulatory Compliance

• Ensure full compliance with applicable

  21 CFR regulations

  (including but not limited to

  21 CFR Part 210, 211, 312, 314, 820

  as applicable).
• Interpret and implement FDA regulatory requirements across manufacturing, quality, and development functions.
  
• Monitor changes in FDA regulations and assess impact on company processes.
  

Documentation & Submissions

• Review, prepare, and maintain regulatory documents such as

  SOPs, validation protocols, batch records, and quality manuals

  .
• Support preparation and review of

  IND, NDA, ANDA, DMF, or 510(k)

  documentation as applicable.
• Ensure data integrity and document control in line with

  21 CFR Part 11

  requirements.

Quality Systems & Audits

• Support implementation and maintenance of

  Quality Management Systems (QMS)

  aligned with FDA standards.
• Participate in and support

  US FDA inspections

  , internal audits, and third-party audits.
• Handle

  CAPA, deviations, change controls, and investigations

  related to regulatory compliance.

Cross-Functional Collaboration

• Coordinate with

  Manufacturing, QA, QC, R&D, Validation, and Supply Chain

  teams to ensure compliance.
• Provide regulatory guidance during product development, scale-up, and technology transfer.
  

Training & Guidance

• Conduct training programs on

  21 CFR and FDA compliance requirements

  for internal teams.
• Act as a subject matter expert for regulatory and compliance-related queries.

Skills & Competencies

• Strong knowledge of

  21 CFR regulations

• Excellent documentation and regulatory writing skills
  
• Analytical and problem-solving abilities
  
• Strong communication and stakeholder management skills
  
• Attention to detail and compliance mindset
  

Preferred Attributes

• Experience with

  electronic quality systems

• Exposure to global regulatory environments
  
• Ability to work independently and lead initiatives