Product Compliance Specialist

Lead and coordinate cross-functional teams to ensure the CMO’s seamless product development

Expanded Responsibilities:

• Serve as the primary CMC lead interfacing with the CMO’s internal functional groups (Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain, Analytical Development, Validation) and external partners/sponsors.

• Drive alignment across technical teams to ensure process development, scale-up, validation, and commercial readiness milestones are met.

• Identify cross-functional risks and proactively implement mitigation strategies.

• Ensure clear communication of technical updates, risks, and key decisions to senior leadership and external stakeholders.

• Promote adherence to cGMP standards and company quality systems across all functional areas

Manage the CMO’s project timelines and budgets related to CMC activities. 

Expanded Responsibilities:

• Develop and maintain detailed CMC project timelines spanning development, validation, regulatory submission, and lifecycle management phases.

• Track progress against key milestones including:

• Process development

  • Method development and validation

  • Engineering and process validation batches

  • Stability studies

  • Regulatory submission deadlines

• Monitor and manage CMC budgets, including:

  • Manufacturing campaign costs

  • Analytical testing costs

  • Validation expenses

  • External vendor/CMO services

Oversight of the CMO’s deliverables related to ensure all aspects of manufacturing, testing, and analytical development meet stringent regulatory requirements. 

Expanded Responsibilities:

• Ensure all CMC activities comply with global regulatory standards including FDA, EMA, ICH, and other applicable authorities.

• Oversee:

  • Process development and scale-up activities

  • Analytical method development, qualification, and validation

  • Process validation and continued process verification

  • Stability program design and monitoring

• Review and approve key technical documentation including:

  • Batch records

  • Validation protocols and reports

  • Analytical methods and specifications

  • Change controls and deviation investigations

• Ensure manufacturing processes adhere to cGMP requirements and data integrity standards.

Initiates and designs the development and revision of operating procedures, policies,Oversight of the CMO’s deliverables related to develop and submit CMC sections of regulatory dossiers to agencies like the FDA and EMA. 

Expanded Responsibilities:

• Lead the preparation, review, and finalization of CMC sections for regulatory submissions, such as INDs

• Coordinate compilation of manufacturing, analytical, validation, and stability data for submission.

• Ensure consistency between Quality Overall Summary (QOS) and detailed technical sections.

• Collaborate with Regulatory Affairs to address agency queries, deficiency letters, and information requests.

• Support preparation of responses to FDA/EMA questions within required timelines.

• Ensure lifecycle management updates (e.g., process changes, site changes, specification updates) are accurately reflected in post-approval submissions.

• Maintain regulatory intelligence awareness to anticipate evolving CMC requirements.