
Manager-Regulatory Affairs
3 weeks ago
Organization : - Jubilant Ingrevia Limited
Designation & Level: - Deputy Manager (L3)
Location : - Noida/Greater Noida/Gajraula/Mumbai/Bharuch/Vadodara/Savli/Nira/Ambernath/Hyderabad
Direct Reports : - IC role
Qualification:
Master's degree in Toxicology, Pharmacology, Biochemistry, Chemistry or other life science.
Experience Range:
7-12 years
Job Context:
To maintain compliance scheme for both Domestic & International regulations like EU REACH, , with other REACH-like regulations of specialty chemicals, as well DMF filing, life cycle management of active ingredients /supplements category. As the Regulatory Compliance Manager, you will be accountable for leading product regulatory activities in the various region through monitoring, developing and implementing strategies/programs to ensure compliance with the required chemical control laws.
Accountabilities:
Regulatory Compliance & monitoring
- Ensure compliance with existing domestic and international chemical regulations governing industrial chemicals, fine chemicals & specialty chemicals.
- Proactively monitor, evaluate business impact and communicate new and amended legislation and regulations.
- Act as a SPOC for DMF & Regulatory filing /amendment in various geography, like in US, EU, WHO, Japan, ROW , CDSCO etc.
- Ensure complete life cycle management of DMF /Dossiers for APIs/active ingredients/intermediates, such as DMF filing, access request, address technical queries of agency & customers, change notification, LOAs, and amendment.
- Managing a data base and RA filing plan across the product value chain in various geography
- Coordinate with internal teams on DMF filing requirements and ensure readiness of all data.
- Review of relevant documents and DMF prior to filing and ensure right first time filing approach
- Addressing customer/regulatory queries within time line with the help of internal CFTs collaborations
Pre-registration / Registration of chemicals and Maintenance
Responsible for preparation & filing of pre-registration and registration dossiers of chemicals under EU REACH, Korea REACH, UK REACH, Turkey REACH etc.
Upgrading / downgrading registered tonnage band as per business requirement and maintenance of the dossiers as per the current requirements.
Assessment of New Product Regulatory Requirements
Provide regulatory guidance/consultancy to the business and R&D teams on compliance strategies for new and existing products.
Substance Volume Tracking
Responsible for maintaining and monitoring the export volume of the products through the ERP system to comply with the registered volume in the respective countries.
Hazard Communication
Review of Safety Data Sheets & Labels of the hazardous products.
Customer Queries & Questionnaires
Provide regulatory inputs on the customer queries & questionnaires.
-
Regulatory Affairs Executive
14 hours ago
Noida, Uttar Pradesh, India SR Strategy Services Full time ₹ 3,00,000 - ₹ 6,00,000 per yearRegulatory Executive (Medical Devices & IVDs)Experience:1–3 years inregulatory affairs for medical devices and/or IVDs under Indian MDR 2017Location:Noida (On-site)CTC :INR 3-6 LPAAbout SR Strategy Services LLP:SR Strategy Services LLP is a leading consulting firm specializing in strategic government affairs, regulatory advisory, market access solutions,...
-
Regulatory Affairs Specialist
2 weeks ago
Noida, Uttar Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000Job OpportunityRegulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs Specialist to join our team.This role is responsible for ensuring compliance with regulatory requirements and guidelines.Key responsibilities include project planning, coordination, and execution.The ideal candidate will have excellent communication and interpersonal...
-
Regulatory Affairs Specialist
1 week ago
Noida, Uttar Pradesh, India Gentell Full time ₹ 15,00,000 - ₹ 28,00,000 per yearGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...
-
Cosmetic Regulatory Affair Specialist
2 weeks ago
Noida, Uttar Pradesh, India CbayExpress Full time ₹ 1,04,000 - ₹ 1,30,878 per yearJob Position:Cosmetics Regulatory Affairs SpecialistWorking Days:Monday to FridayShift Time:12 PM IST- 9 PM ISTWe are looking for a detail-oriented and knowledgeable Cosmetics Regulatory Affairs Specialist to joinour team. The ideal candidate will have a strong understanding of regulatory policies, documentation,and compliance requirements related to...
-
Cosmetics Regulatory Affairs Specialist
7 days ago
Greater Noida, Uttar Pradesh, India CbayExpress Full time ₹ 7,80,000 per yearJob Position: Cosmetics Regulatory Affairs SpecialistWorking Days: Monday to FridayShift Time- 12 PM IST- 9 PM ISTLocation- Sector- 63, Noida We are looking for a detail-oriented and knowledgeable Cosmetics Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong understanding of regulatory policies, documentation, and...
-
Drug Regulatory Affairs Executive
2 weeks ago
Noida, Uttar Pradesh, India Florencia Healthcare Full time ₹ 15,00,000 - ₹ 28,00,000 per year1. Drug Regulatory Affairs - Job descriptionPrepare CTD, ACTD Dossiers and file regulatory submissionsPerform assessments of new or revised productsManage complaint documentation (including investigation andclosure)Respond to inquiries from regulatory bodiesShould be technically well versed with requirements for Medicineswith fare knowledge about Food...
-
Manager-Regulatory Affairs
2 weeks ago
Noida, Uttar Pradesh, India Jubilant Ingrevia Limited Full timeOrganization : - Jubilant Ingrevia LimitedDesignation & Level: - Deputy Manager (L3)Location : - Noida/Greater Noida/Gajraula/Mumbai/Bharuch/Vadodara/Savli/Nira/Ambernath/HyderabadDirect Reports : - IC roleQualification:Master's degree in Toxicology, Pharmacology, Biochemistry, Chemistry or other life science.Experience Range:7-12 yearsJob Context: To...
-
Director of Regulatory Affairs
3 weeks ago
Noida, Uttar Pradesh, India Vahura Full timeA leading Chartered Accountancy firm in Noida is seeking a dynamic leader to head its expanding Regulatory Division. This role offers the chance to shape strategy, drive growth, and deliver regulatory advisory and compliance solutions to prominent corporate clients across sectors. The right professional will bring at least 12 years of post-qualification...
-
Director of Regulatory Affairs
2 weeks ago
Noida, Uttar Pradesh, India Vahura Full time ₹ 15,00,000 - ₹ 20,00,000 per yearA leading Chartered Accountancy firm in Noida is seeking a dynamic leader to head its expanding Regulatory Division.This role offers the chance to shape strategy, drive growth, and deliver regulatory advisory and compliance solutions to prominent corporate clients across sectors.The right professional will bring at least 12 years of post-qualification...
-
Regulatory Affairs Specialist
2 weeks ago
Noida, Uttar Pradesh, India beBeeCompliance Full time ₹ 11,52,000 - ₹ 15,36,000Key Responsibilities:Compliance Audit and ReportingConduct thorough reviews and maintain accurate documentation to ensure adherence to regulatory requirements and internal standards.CORPORATE GOVERNANCE REVIEWEvaluate the organization's governance framework to ensure alignment with regulatory expectations and industry best practices.Internal Controls and...