Senior Executive, Compliance

This is a fully remote position, open to applicants in India.

📋 Description

• Responsible for managing Compliance-related change controls concerning license updates, ensuring timely progression and closure of these changes.

• Identifying business and Quality requirements along with the criticality of recognized license non-compliances and addressing license gaps based on this assessment.

• Drafting necessary Quality-related submission documents as required.

• Appropriately managing workload with the capability to swiftly re-prioritize tasks when necessary.

• Regularly communicating with Regulatory to ensure alignment of submission priorities and that quality-critical submissions are prioritized.

• Reviewing and approving essential Module 3 documents prepared by Regulatory before submission to ensure compliance with CTD standards.

• Managing related submission RFIs within specified timelines.

• Acting as the Quality Compliance owner for Technical Transfers projects, performing gap assessments between potential CMOs and current registered information while adhering to established project timelines.

• Collaborating with external stakeholders, including Contract Manufacturing Organizations, and fostering key relationships.

• Serving as the Quality Compliance Subject Matter Expert (SME) for projects led by both the Compliance team and other departments.

⛳️ Requirements

• A minimum of a Degree in Chemistry, Pharmacy, or Microbiology.

• At least 5 years of experience in a comparable role within the pharmaceutical industry.

• Comprehensive knowledge of GxP regulations across all dosage forms.

• Proficient in authoring Module 3 in CTD format.

• Experience in interpreting manufacturing and testing information (Critical vs. Non-critical) for submission purposes.

• Demonstrated ability to ensure that Module 3 contains accurate, adequate, and appropriate data to facilitate right-first-time submissions.

• Experience in drafting supporting submission documents (e.g., justifications for post-marketing changes and responses to RFIs).

• In-depth knowledge of Quality Management Systems (QMS), particularly regarding change controls, risk assessments, and continuous improvements.

• Ability to meet deadlines and maintain composure under pressure.

• Proven capability to organize and prioritize multiple tasks effectively.

• Ability to work efficiently as part of a team and across different functions.

🏝️ Benefits

• Competitive salary.

• Flexible working environment.