Regulatory Compliance Manager
3 days ago
About Alkem Laboratories Ltd.:
A leading Indian multinational pharmaceutical company headquartered in Mumbai, manufacturing and selling pharmaceutical generics, formulations, and nutraceuticals globally.
Job SummaryWe seek a highly skilled Regulatory Compliance Manager to join our team in driving the compliance program across business verticals. This role will ensure seamless documentation and due diligence, adhering to UCPMP guidelines and internal policies.
Main Responsibilities:
- Document Review and Verification: Conduct thorough reviews of pre- and post-event documentation for marketing activities to guarantee compliance with UCPMP guidelines and internal policies.
- Due Diligence and Certification: Perform due diligence on in-scope parties and maintain reports and data, ensuring accuracy and timeliness.
- Data Management and Reporting: Manage data, create MIS reports, prepare UCPMP reports in specified formats, conduct data analysis, and develop management presentations using Excel proficiency.
- Team Supervision and Escalation: Supervise pre- and post-event documentation team members, handle escalations, and provide guidance as needed.
- Collaboration and Training: Collaborate with Commercial, Medical, Regulatory Affairs, Clinical Operations, Internal Audit, Legal, Human Resources, Finance, and other teams as required, providing support for training and monitoring.
- Continuous Improvement: Contribute to the enhancement of Alkem's compliance program by sharing insights, recommending enhancements, and implementing updates.
- Digitization and Process Improvement: Support the Head of Business Ethics & Marketing Compliance in digitizing compliance processes and controls and other initiatives as required.
Requirements:
- Graduate/Post Graduate from an accredited university.
- PREFERRED EXPERIENCE: 8-12 years of pharmaceutical or healthcare experience in documentation and due diligence.
Salary Estimate: ₹15,00,000 - ₹20,00,000 per annum, based on qualifications, experience, and location.
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