Regulatory Affairs & Safety
- Reckitt
- 4 - 8 years
- Noida, Gurugram
- 3 months ago
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Job Description
- Manage daily operations of regulatory function of the assigned category
- Liaise with a range of colleagues from Marketing, R&D, supply, and global/regional regulatory teams.
- Maintain Regulatory Databases
- Review, interpret and assess impact of the regulatory changes.
- To manage compliance activities for Sustainability under Plastic waste management, Battery waste
management and E-waste management rules across Reckitt entities & portfolio
- Preparation, maintenance and update of product registration/license and regulatory compliance files.
- Compilation of registration dossiers for submissions to authorities
- Coordination with central and state regulatory authorities/ FDAs for necessary product approvals.
- Preparation, maintenance and update of product registration/license and regulatory compliance files.
- Amend the registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration/variation applications and negotiating with governmental authorities to obtain rapid approvals.
- Compiling Compliance Dossiers for manufacturing of products for the local market.
Managing and maintaining regulatory documentation filing system.
- Ensure compliance with local Pharmacovigilance, Medical Device Vigilance, Nutravigilance and Cosmetovigilance (Vigilance) guidelines and the requirements of the Reckitt Benckiser global vigilance
system.
- Ensure local AEs are collected from all sources and reported to the GVG within RB assigned reporting timelines, and appropriate follow up is undertaken.
- Submit ICSRs, Medical Device Incidents and Serious Undesirable Events to the local Competent Authority (CA) as required, working in collaboration with the GVG.
- Ensure up to date knowledge of the local regulatory legislation / requirements and advise the GVG of changes as appropriate.
- Ensure that the National Business Unit has a 24-hour number set up to allow adverse event reports and enquiries to be dealt with by an appropriately qualified service outside normal office hours.
- Ensure all local Third Parties/contractors are aware of their vigilance obligations, trained appropriately and Vigilance agreements are in place.
- Ensure all local employees are trained appropriately, with documentation, regarding their vigilance obligations and are aware how to report an adverse event should they become aware of one. All training folders must be maintained.
- Ensure all local activities and quality systems are reflected in SOPs which have been reviewed by the local
NBU and signed off by the appropriate local NBU team and the Qualified Person for Pharmacovigilance (QPPV).
- Provide compliance metrics to the QPPV every month.
- Ensure the QPPV is notified whenever a Pharmacovigilance Inspection is announced in the NBU and work with the GVG to ensure compliance.
- Ensure that a named deputy is in place and trained to cover all activity in the absence of the DSO.
Any other activities relevant to the global vigilance system as requested.
Assist team in Ariba, Payment
- Assist team in Vendor Onboarding
EXPERIENCE/QUALIFICATION
Education:
- Postgraduate in Master of Business Administration (Pharmaceutical Management)
- Graduate in Pharmacy
Experience:
- 4-5 years experience in FMCG/Pharma Industry in the field of pharmaceutical, general category products.
Job Classification
Industry: FMCGFunctional Area / Department: Legal & RegulatoryRole Category: Legal & Regulatory - OtherRole: Legal & Regulatory - OtherEmployement Type: Full timeContact Details:
Company: ReckittLocation(s): Noida, Gurugram+ View Contact
Keyskills: Regulatory Affairs Regulatory Guidelines FDA Regulatory Reports Regulatory Compliance Regulatory Submissions
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