Compliance Manager, India Regulatory Affairs Specialist
1 month ago
Reporting to the Director, Compliance Officer for Medtronic APAC Region, the India Compliance Officer will lead the India Ethics and Compliance Team and will be responsible for overseeing compliance program and relevant initiatives within India.
A Day in the Life- Ensuring Medtronic's Business Conduct Standards and other Compliance Programs and Policies are understood, processes are in place to comply with the requirements, and employees are appropriately trained.
- Developing and advancing Compliance controls and procedures to properly reflect local laws/regulations as well as applicable industry code for India.
- Meaningfully contributing timely, strategic and practical compliance consultations to local Leadership team.
- Ensuring adequate record maintenance and processes are in place to document compliance efforts.
- Participating in the annual risk assessment process and ensure regional work plans are aligned with the compliance risks.
- Collaborating with Regional and other key stakeholder functions to integrate compliance considerations into business processes.
- Fostering the culture of ethical behavior and integrity throughout the organization including channels in conducting business.
- Assisting audit/monitoring review, establishing feasible remedial action plans and corrective measures and supervising the execution and implementation on the ground.
- Mastery of the effectiveness of local Compliance program, leading the standardization and optimization of local workflows to align with company goals and objectives.
CA or Law or MBA degree from an accredited college or university and 10+ years of compliance experience with 7+ years of managerial experience.
Specialized Knowledge or Skills Required
- Prior compliance oversight of complex systems responsibilities preferred, as well as experience in the healthcare industry (particularly medical devices).- Strong understanding of the culture in India, a strong communication skill set to enable effective influence at senior levels.
- Prior success in effectively identifying, assessing and prioritizing compliance-related risks, such as through risk assessment, policies & procedures, training, monitoring, and remediation actions. Nice to Have
Ability to manage and execute multiple complex projects (including those with systems responsibilities) across multiple stakeholder groups within required timelines and expectations required.
Understand complex and diverse compliance environments and ability to work effectively with multi-divisional teams in different locations / businesses / geographies to ensure compliance particularly in matrixed and/or multinational organizations.
Ability to work effectively in a team environment and build strong working relationships, involving multiple business functions, units, and/or geographies.
Proven execution under pressure and ability to maintain positive, enthusiastic attitude.
Exceptional interpersonal, oral, presentation, and written communication skills, including to senior leaders/executive audiences.
Ability to identify high risk situations and provide appropriate guidance, including the ability to make courageous and unpopular decisions.
Ability to make an impact and influence at all levels of employee and management groups, including executive leaders, to implement compliance program initiatives.
-
Regulatory Affairs Specialist
17 hours ago
Mumbai, Maharashtra, India Lifelancer Full timeWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer in Mumbai, India. As a key member of our Regulatory Operations department, you will be responsible for ensuring compliance with regulatory requirements across various product categories.The ideal candidate will have a BS degree in Pharmacy or Life Sciences and 1+...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India SUN PHARMA Full timeJob Title: Regulatory Affairs SpecialistKey Responsibilities:Ensure compliance with regulatory requirements for API Plant operations.Manage DMF compilation and lifecycle management.Coordinate change control and related submissions.Develop and maintain quality standards.Requirements:Qualifications:Minimum 2 years of experience in regulatory affairs or quality...
-
Regulatory Affairs Specialist
4 weeks ago
Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 1925 GlaxoSmithKline LLC.About the RoleAs a Regulatory Affairs Specialist, you will be responsible for ensuring the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital...
-
Regulatory Affairs Specialist
4 weeks ago
Mumbai, Maharashtra, India Genpact Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Genpact. As a Lead Regulatory Affairs Expert, you will play a critical role in ensuring compliance with labeling regulations and guidelines.Key ResponsibilitiesLiaise with key interfaces to ensure project requirements are met and timelines are mutually...
-
Regulatory Affairs Specialist
4 days ago
Mumbai, Maharashtra, India Piramal Group Full timePiramal Pharma Solutions Department: Corporate Regulatory Affairs Job Overview: We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Kurla. The successful candidate will be responsible for the submission of regulatory dossiers for targeted markets, ensuring compliance with CDMO and Agile businesses. Key Stakeholders: Sites –...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India Counselect Services Private Limited Full timeRegulatory Affairs Role OverviewCounselect Services Private Limited is seeking a skilled Regulatory Affairs Specialist to join their team. This role involves handling the regulatory function for drugs, cosmetics, and food products in both domestic and international markets.The ideal candidate will have knowledge of regulations such as the Drugs and Cosmetics...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India Piramal Group Full time**Job Overview:**The Regulatory Affairs Specialist will be responsible for providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, and collaborating with others in the organization to contribute to the success of the business.**Key Responsibilities:**Prepare Red Books for key...
-
Regulatory Affairs Specialist
17 hours ago
Mumbai, Maharashtra, India Lifelancer Full time**Overview of Regulatory Affairs Role in Life Sciences**Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma, and IT, is seeking an experienced Regulatory Affairs Specialist to join our team. This role plays a critical part in ensuring compliance with regulatory requirements for product registration, maintenance, and advocacy.The ideal...
-
Regulatory Affairs Specialist
4 weeks ago
Mumbai, Maharashtra, India Piramal Group Full timeBusiness: Piramal Critical Care Department: Regulatory AffairsLocation: Kurla, MumbaiTravel: LowJob OverviewAs a Regulatory Affairs Specialist, you will be responsible for managing Regulatory Filings for Europe with minimal supervision.Key Stakeholders: InternalCountry manager, Plant, QA, Artwork department, Supply Chain, PVKey Stakeholders: ExternalHealth...
-
Medical and Regulatory Affairs Specialist
4 weeks ago
Mumbai, Maharashtra, India Piramal Group Full timeJob Overview: We are seeking a highly skilled Medical and Regulatory Affairs Specialist to join our team at Piramal Group. The successful candidate will be responsible for providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, and providing scientific training for marketing...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India Sun Pharma Advanced Research Company Ltd. Full timeJob Summary:Sun Pharma Advanced Research Company Ltd. is seeking a highly skilled Regulatory Affairs Specialist to support the development and execution of regulatory strategies for our pharmaceutical products. The ideal candidate will have a strong background in CMC regulatory affairs and excellent communication skills.Key Responsibilities:Authoring CMC...
-
Regulatory Affairs Manager
1 month ago
Mumbai, Maharashtra, India 1925 GlaxoSmithKline LLC Full timeJob DescriptionAs a Regulatory Affairs Manager at 1925 GlaxoSmithKline LLC, you will be responsible for leading global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures, and...
-
Mumbai, Maharashtra, India Parexel Full timeAbout this RoleParexel is seeking a highly skilled Senior Regulatory Affairs Associate to join our team in a labeling specialist role. This individual will be responsible for ensuring compliance with key labeling regulations and guidelines.Key ResponsibilitiesCollaborate with cross-functional teams to ensure accurate and compliant labeling.Develop and...
-
Regulatory Affairs Associate Manager
1 month ago
Mumbai, Maharashtra, India Kenvue Full timeRegulatory Affairs Associate Manager Job DescriptionThis position reports to the Director-Regulatory Affairs and is based at Mumbai.Key Responsibilities:Contribute to India Regulatory strategy development and ensure timely execution on all deliverables in an agile manner.Collaborate with business partners to provide regulatory strategies and support for...
-
Regulatory Affairs Expert
3 weeks ago
Mumbai, Maharashtra, India General Mills Full timeJob Title: Regulatory Affairs Leader Job Summary: We are seeking a skilled Regulatory Affairs Leader to monitor regulatory changes and status in multiple markets, including India, the Middle East, and Southeast Asia. The successful candidate will conduct impact assessments for regulatory changes and partner with the business to build readiness plans. ...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India Piramal Group Full timeBusiness: Piramal Pharma Solutions Department: Corporate Regulatory Affairs Job OverviewWe are seeking a skilled Regulatory Affairs Specialist to join our Corporate Regulatory Affairs team at Piramal Pharma Solutions. In this role, you will be responsible for submitting regulatory dossiers for targeted markets as per business needs to support CDMO and Agile...
-
Regulatory Compliance Specialist
4 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeAbout the RoleAs an Associate Regulatory Specialist, you will handle key regulatory activities like raw material data management compliance workflows and change management to ensure regulatory compliance for Diversey products.The person will be reporting to the Manager Regulatory Affairs.As a Regulatory Expert, your key responsibilities will...
-
Regulatory Compliance Specialist
1 month ago
Mumbai, Maharashtra, India Lifelancer Full timeAbout the RoleAs an Associate Regulatory Specialist at Lifelancer, you will be responsible for handling key regulatory activities such as Raw Material Data Management compliance workflows and change management to ensure regulatory compliance for Diversey products.The person will be reporting to the Manager Regulatory Affairs.Key Responsibilities:Perform raw...
-
Regulatory Affairs Specialist
3 weeks ago
Mumbai, Maharashtra, India Apotex Full timeAbout ApotexApotex is a global health company that produces high-quality, affordable medicines. The company employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in over 75 countries. Through vertical integration, the Apotex group focuses on developing and selling generic,...
-
Regulatory Compliance Specialist
3 weeks ago
Mumbai, Maharashtra, India Lifelancer Full timeAbout Regulatory ComplianceThe role of Associate Regulatory Specialist at Lifelancer involves handling key regulatory activities such as Raw Material Data Management compliance workflows change management to ensure regulatory compliance for Diversey products. The successful candidate will report to the Manager Regulatory Affairs.Key Responsibilities:Perform...