3210 Regulatory Affairs Jobs - Page 37

Our Client a reputed Pharma company - Post : Deputy Medical Manager Services & PVOI Gender : Female Location : Lower Parel, Mumbai Experience : Min 2 years in Medico Marketing within the Pharmaceutical Industry Qualification : M. Pharm (Pharmacolgy) / D. Pharma Job Profile Provide scientific support to brands by delivering the latest scientific information on products, therapy areas, and clinical guidelines Develop and ensure the quality of scientific materials, including Product Monographs, LBLs, VAs, PSIs, PIs, and PLIs Conduct medical training sessions and product training for field personnel Contribute to new product ideation, including indication expansion, unique dosage forms, and nove...

End-to-end management of regulatory submissions for finished dosage forms. Prepare & compile high-quality dossiers (Modules 1–5). Coordinate cross-functional teams, handle queries, ensure compliance, and support lifecycle mgmt of products.

Role Overview: Would you like to join an international team at Grifols, a global healthcare company dedicated to improving the future of healthcare and enhancing the lives of millions of people worldwide As the National Sales Manager for the Diagnostics Division, you will lead and manage commercial operations across India and South Asia. Your role will involve driving sales performance, market access, and strategic partnerships in alignment with global and regional goals. Grifols believes in the value of diversity and is committed to providing equal employment opportunities in an inclusive environment. Key Responsibilities: - Lead and develop the overall sales performance of the assigned ter...

Job Description Role Overview: As a Sr Manager Drug Regulatory Affairs at Jaidev Pharma Placement, your primary responsibility will be to ensure regulatory compliance and manage regulatory requirements. You will oversee regulatory affairs, handle regulatory submissions, and maintain the quality system. This is a full-time on-site role located in Chandigarh. Key Responsibilities: - Ensure regulatory compliance - Manage regulatory requirements - Oversee regulatory affairs - Handle regulatory submissions - Maintain the quality system Qualifications Required: - Regulatory Compliance and Quality System management experience - Understanding and implementing Regulatory Requirements - Proficiency in...

Act as Technical Product Owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements. Gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness. Good experience in Regulatory Affairs and worked on Veeva and Acumulus. Should be from Pharma domain only . Manage product backlogs in JIRA , defining clear user stories, acceptance criteria, and prioritization based on business value. Collaborate with development, QA, and regulatory teams to ensure product features meet both technical specifications and regulatory standards. Facilitate workshops, requirement-gath...

Regulatory Affairs professional with knowledge of D&C Act, Rules, and FSSAI regulations. Experienced in Domestic Market only.

Job Position: Cosmetics Regulatory Affairs Specialist Working Days: Monday to Friday Shift Time- 12 PM IST- 9 PM IST On-Site Role 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 compliance requirements related to cosmetics. This role will be responsible for ensuring that all products meet local and international regulatory standards. Key Responsibilities: • Prepare and submit regulatory documentation for cosmetic product approvals and registrations. • Ensure compliance with all relevant regulations, guidelines, and standards related ...

Guhring India Pvt Ltd is looking for Quality professionals to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

To prepare and distribute the development work and to counter check the work and documentation and releasing the development report. To check the technical feasibility with artworks and for the product developed by Designers. To resolve the queries raised by semi regulatory market / regulatory market / other regulatory market. To participate in market complaint and provide support in identify root cause. To ensure timely support for new artworks and development to International Regulatory Affairs (IRA) department, marketing department, Business Development dept. To adapt new & more effective / more advanced methods of packaging developments To keep track of regulatory commitments and ensure ...

Regulatory Compliance Product Registration & Approvals Safety & Risk Management Audit Support Cross-functional Collaboration Import/Export Control

Role & responsibilities To be well versed about coordination and collaboration with Quality functions of third party manufacturing (CMO) sites and CMO team for compliance of product, facility, systems, procedures. and for documents required from third party for various purpose; review, RA submission etc. Must have knowledge and know how on regulatory pathway for registration of product as per third party and or loan license norms/rules and requirement of documentation for regulatory submissions. Incumbent is expected a good reviewer and investigator To know the function of oversight of CMO sites for batch/lot releases as applicable form the manufacturing (Feed supplements and Pharma products...

Lead the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. Provide expert leadership overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics. Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance. Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs). Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robust...

Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures. Manage clinical and third-party data reconciliation based on edit specifications and data review plans. Tracks and communicates status of study and task metrics to clinical data scientist, project team, and functional management. Address data related questions and recommend potential solutions. Identify root cause to systematically resolve data issues. Your profile Bachelors degree in a relevant field, such as Life Sciences or Healthcare. Intermediate kNwledge of clinical data management within the pharmaceutical or biotechNlogy industry. Familiarity with data management s...

Job Responsibilities: This position is required to achieve the desired level of performance in the following Key Result areas: To provide solutions to compliance issues, in-house, wherever possible. Managing regulatory affairs of the business corresponding with various central, state and local government departments, quasi-judicial offices, to get licenses, manage inspections, seizures, raids, adjudications and all other proceedings under Food Safety and Standards Act, Essential Commodities Act, Shops and Establishments Act, Municipal Corporation laws, Legal Metrology Act, labour laws and other laws affecting retail trade operations. Handling legal compliances of the company and other group ...

1) Regulatory lifecycle of ISTS Projects 2) Handling Section 68 / Section 164 permits and approvals 3) COD, First Time Charging (FTC), Trial Runs, and ISTS Connectivity Agreements 4) Liaising with PGCIL, CTU, DISCOMs, and Government agencies

Job Description: 1 . Hands on Experience in regulatory submissions preferably for Blood products and Biologics. 2. Review/Submission of applications for new products Manufacturing licenses and renewals. 3. Experience on procedures for application of new drugs (NOC's and Test licenses). 4. Monitoring and ensuring allp certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. 5. Review of Tender certificate. 6. Co-ordinate with Drug control authority personnel for License approvals. 7. Review of Dossiers. 8. Submission of Samples and Documents to NIB, Noida for testing. 9. Updation of the National and international legisl...

Job Overview The Executive Pharmacovigilance will be responsible end-to-end case management, including case receipt, case follow-up,database entry, review and submission to applicable regulatory authorities within stipulated timelines. Required Candidate profile Any Pharmacy or Pharm D with Certification in Pharmacovigilance can Apply Should have Good Communication Skills Should have strong knowledge on Argus Safety Database and Case Processing and MedDRa

JOB RESPONSIBILITIES: Job Title: Manager/Sr. Manager Exp- 10- 15 Years Ability to handle prior art/patentability / invalidation and FTO searches. Making of Landscape preparation and patent monitoring of drug products for the proposed Active Pharmaceutical Ingredients (API). -Conducting Infringement/FTO Analysis for API for countries of interest and provide clearances to CRD. Freedom to operate analysis-Drug product-based, Technology-based and packing based. Orange book patent analysis-critical non-infringement strategy. Collaboration with R&D scientists, analysts regarding patent issues. Taking of attorney opinions for proposed invalidity or non-infringement study wrt the proposed route of s...

Job Description 3 to 5 years of SAP EHS experience (support/projects) with cross-functional skills (SD, MM). Deliver services in HSE area (both SAP & non-SAP) in solution design, build, testing, implementation and application management services Skills : Strong functional and business process knowledge across all SAP EHS areas like Product Safety, WWI, Dangerous Goods, Product compliance and risk/incident management. Strong understanding of all context e.g. regulatory framework relevant for EHS especially for NA & EU . Knowledge/work experience on non-SAP HSE tools (any Saas tools) is an added preference. Excellent functional and technical understanding of the integration requirements for SA...

Key Responsibilities: • Maintain effective communication with local, state, and central government bodies. • Navigate and manage compliance issues related to any changes in government policy. • Train and educate store staff and internal teams on compliance-related matters. • Ensure transparency, confidentiality, and honesty during all interactions with government departments. • Handle negotiations with government officials as needed.

Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing whatever your ambitions. Location: Gurugram, India Key Responsibilities Compilation of Medical Device Dossier w.r.t Indian regulatory requirements for Registration, Clinical Trial Permissions, License Transfers, Import ...

Job Title: Sr. Manager / DGM Business Unit: Sun Global Operations Job Grade G9A/G8 Location : Gurgaon At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys. Key responsibilities: Serve as a Regulatory CMC Product Lead and provide CM...

Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing whatever your ambitions. Location: Gurugram, India Key Responsibilities Compilation of Medical Device Dossier w.r.t Indian regulatory requirements for Registration, Clinical Trial Permissions, License Transfers, Import ...

Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing whatever your ambitions. Location: Gurugram, India Key Responsibilities Compilation of Medical Device Dossier w.r.t Indian regulatory requirements for Registration, Clinical Trial Permissions, License Transfers, Import ...

We are hiring a highly qualified and experienced Company Secretary to join our leadership team. Key Responsibilities: 1. Compliance & Regulatory Affairs: Ensure compliance with the Companies Act, 2013 and other applicable Laws. Maintain statutory records and registers, including maintenance of Minutes of meetings of Board and members. Ensure timely filing of Returns with ROC (Registrar of Companies) and other Statutory Bodies. Ensure timely compliance with FSSAI, NABL, ICMR, and other healthcare industry regulations. 2. Corporate Governance & Secretarial Duties: Prepare and circulate Notice (s), agenda and resolutions for meetings of Board , Meetings of Committee . Organize and conduct meeti...