Regulatory Affairs Specialist
7 days ago
Role -Formulation Regulatory Affairs - for Peptide products or Injectables Level - Deputy Manager/ Associate ManagerRequired Education/Ex p: Experience Req.: 8 - 12 yrs. Qualification: - M. Pharma / M.Sc.Key Role-Formulation Regulatory Affairs for Peptide products or InjectablesResponsibiliti es: Drafting controlled correspondences, pre-development meetings and scientific advices for seeking regulatory feedback on various topics from different Health-Agencies especially for peptides products & Injectables. Prepare a regulatory submission strategy, checklist for administrative and technical documents for each submission considering country specific requirements for peptide products. Compilation of CTD sections and supporting documents from Module 1 to 5 with respect to each Health-Agencies and ensure the regulatory compliance to most current requirements. Prepare a draft response to queries raised by the Health agencies / Business partner with supporting updated documents. Ensure to respond within the prescribed timelines. Review and provide Technical inputs during product life cycle starting from developmental documents, drug-device combination product and clinical/non-clinical proposals. Co-ordinate with all cross-functional teams and regularly updating the status tracker/checklists and keep updating reporting head. Any other responsibilities vested by reporting head based on requirements.Required sk ills :- Hands on expertise of handling Peptide or Injectable products. Peptide Regulatory Exp will be prefered more. Well versed with regulatory gui delines.Candidates with relevant exp., kindly share CVs to apply on :- rashmi.gupta@biocon.comKindly mention below details whilesharing CV :-Total Exp? Current CTC? Handling exp of Peptide Regulatory or not? Notice Period? Ready to work in Bangalore (onsite) ? (5 Days working)
-
Regulatory Affairs Specialist
3 weeks ago
New Delhi, India Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation:At Ahmedabad Office , Near Thaltej Crossroads Department:RA Reports To:RA Head and Regulatory Department at HO /Director Employment Type:Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday andSaturday Half Day Preferred Gender: M/F Experience : Minimum 2 yearsJob Summary: We are seeking a proactive...
-
Regulatory Affairs Specialist
2 weeks ago
New Delhi, India UpMan Placements Full timeCore Job Responsibilities: Regulatory Submissions and compliance Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA Prepare and submit...
-
Regulatory Affairs Officer
1 week ago
Delhi, India NKG ADVISORY BUSINESS AND CONSULTING SERVICES PVT LTD Full timeRegulatory Affairs Specialist - Legal Metrology and EPR India **Responsibilities**: Regulatory Compliance: Stay up-to-date with the latest Legal Metrology and EPR regulations in India. Ensure that all products and processes comply with these regulations. Documentation: Prepare and maintain all necessary documentation required for regulatory submissions,...
-
New Delhi, India Danaher Full timeThis job is with Danaher, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and...
-
Regulatory Affairs Specialist
5 days ago
New Delhi, India Shiv Nadar School Full timeJob Title:Senior Manager –Regulatory Affairs & Legal Compliances Location:Core Office, Noida Employment Type:Full-timeJob Summary: We are seeking a detail-oriented and proactive professional to oversee the organization’s legal, regulatory, and compliance functions. The incumbent will be responsible for ensuring adherence to statutory requirements,...
-
Regulatory Affairs Specialist
4 days ago
New Delhi, India Shiv Nadar School Full timeJob Title: Senior Manager – Regulatory Affairs & Legal CompliancesLocation: Core Office, NoidaEmployment Type: Full-timeJob Summary:We are seeking a detail-oriented and proactive professional to oversee the organization’s legal, regulatory, and compliance functions. The incumbent will be responsible for ensuring adherence to statutory requirements,...
-
Regulatory Affairs Manager
4 weeks ago
New Delhi, India Self-employed Full timeCompany Description Founded in the commercial operations year of , NextGen Pharma, a majority-owned subsidiary of Ormendes SA, Switzerland, has emerged as a leading provider of specialized botanical and nutraceutical solutions. With a focus on proprietary Targeted Bacterio-Therapy (TBT), our offerings cater to diverse therapeutic segments ranging from...
-
Regulatory Affairs Officer
2 weeks ago
Delhi, India NKG ADVISORY BUSINESS AND CONSULTING SERVICES PVT LTD Full time**Job Title: Cosmetics Regulatory Affairs Specialist - Delhi** Key Responsibilities: - Conduct regulatory assessments of cosmetic products to ensure compliance with relevant regulations and guidelines - Prepare and submit regulatory dossiers to the appropriate authorities for import registration of cosmetics under COS 02 and COS 04 categories - Stay...
-
Regulatory Affairs Specialist
6 days ago
Bengaluru, Delhi, NCR, Vellore, India Airvin Skills Full time ₹ 2,00,000 - ₹ 8,00,000 per yearEWe are looking for a passionate and detail-oriented Regulatory Affairs Specialist (Fresher) to join our life sciences and healthcare compliance team. The ideal candidate will be responsible for assisting in the preparation, review, and submission of regulatory documents and ensuring adherence to national and international standards for product approval and...
-
Regulatory Affairs Cdsco Executive
2 weeks ago
Delhi, Delhi, India Professional Utilities Full timeWe are currently seeking a proactive and dedicated Regulatory Affairs Specialist to join our team of business consultants. The primary responsibility of this role is to assist our clients in obtaining the necessary licenses and registrations from the Central Drugs Standard Control Organization (CDSCO) to establish and operate their pharmacy shops...