Senior Regulatory Affairs Officer

2 weeks ago

Ahmedabad, Gujarat, India Lifelancer Full time

Job Title: Senior Regulatory Affairs Officer

Job Location: Ahmedabad, Gujarat, India

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level: Associate

Skills:
Regulatory Affairs, Quality Assurance, Regulatory Strategy Development, Class III Medical Devices, Product Registration, international legislation, accreditation requirements, Regulatory Compliance, Title/Designation: Senior Regulatory Affairs Officer Based at: Ahmedabad Industry: Class III Medical Devices Qualification:Postgraduate or equivalent in Pharma/ Medical devise Sector (PhD preferred) Experience: Min. 5-6 years in Certifications and Regulatory documentation Reports to: RA Manager Salary: Commensurate with experience About us: Aegis Lifesciences is a globally recognized leader in the manufacturing and export of medical devices, operating from its state-of-the-art facilities in India. The company specializes in producing high-quality absorbable and non-absorbable hemostats. Since its establishment in 2008, Aegis has successfully expanded its product offerings and global reach, serving even the most quality-conscious markets, including EU, NHS-UK, CIS, Central America, Russia, LATAM, MENA, SA, and SEA. With a remarkable yearly growth rate of over 30%, Aegis has demonstrated significant success in its global operations. Aegis upholds the highest quality standards, holding certifications as ISO:13485, MDSAP, and adhering to GMP standards of multiple countries. The company has received international certificates of CE (Class III medical devices). Furthermore, the Aegis facilities are registered with the United States Food and Drug Administration (FDA), further exemplifying the company's commitment to quality and compliance. About the role: An exciting opportunity in the field of class III / class D Medical devices Certification, QMS & Regulatory Compliances. Responsibilities: Leading new products registration and license renewal in various countries Compliance for international as well as local regulations for various class of medical devices To Lead QA/RA team and ensure quality SOPs within the company Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment Oversee maintenance of product quality and compliance through the Quality Assurance functions as well as management of the Quality Management System and compliance processes Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects Keep abreast of International legislation and guidelines of current product line in India Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production, RA & QA team to provide advice on process and labeling changes Review of SOPs, BPRs, specifications and change control to ensure compliance Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks Drives resolution of issues, communicates issues, impact and outcomes to the management team Responsible for ensuring compliance to the submission standards, procedures and policies in India Support Commercial Department in business development such as product evaluation and pre-launch activities Support Marketing/sales department for product review, product function training, catalogue preparation, content management, field queries resolution etc Candidate requirements: Minimum 5 to 6 years of experience in technical documentation, regulatory affairs and quality assurance in the medical device industry Bachelors degree in relevant field. Master's is desirable Ethical behavior and high level of integrity Good teamwork, independent and committed to works across functional department Possess good negotiation and dispute resolution skills Demonstrated experience operating in a regulated environment Ability to read, analyze and interpret governmental regulations & reports, scientific or clinical publications and data Ability to write reports, business correspondence, and quality procedures Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

https://lifelancer.com/jobs/view/ea40f626809c1a52de10e34b11e71be9

Apply on Lifelancer Platform

  • Senior Regulatory Affairs Officer

    1 week ago

    Ahmedabad, Gujarat, India Lifelancer Full time

    Job Title: Senior Regulatory Affairs Officer Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Skills:Regulatory Affairs, Quality Assurance, Regulatory Strategy Development, Class III Medical Devices, Product Registration, international legislation, accreditation requirements,...

  • Regulatory Affairs Officer

    2 weeks ago

    Ahmedabad, Gujarat, India Lifelancer Full time

    Job Title: Regulatory Affairs Officer / Sr. Officer Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Skills:ROW Market, Prepare Dossiers, Guideline Knowledge, BE Report, AMV, BMR-BPR,Company OverviewBioMatrix Healthcare Private Limited, a leading export-oriented...

  • Trainee Officer Regulatory Affairs

    4 weeks ago

    Ahmedabad, Gujarat, India Biotech Healthcare Full time

    Role Objective:The Trainee Officer – Regulatory Affairs will be responsible for assisting in the preparation, compilation, and review of regulatory documents to ensure compliance with country-specific guidelines. This role provides an opportunity to develop expertise in regulatory requirements, documentation processes, and dossier submissions, contributing...

  • Trainee Officer Regulatory Affairs

    4 weeks ago

    Ahmedabad, Gujarat, India Biotech Healthcare Full time

    Role Objective:The Trainee Officer – Regulatory Affairs will be responsible for assisting in the preparation, compilation, and review of regulatory documents to ensure compliance with country-specific guidelines. This role provides an opportunity to develop expertise in regulatory requirements, documentation processes, and dossier submissions, contributing...

  • Regulatory Affairs Executive API PHARMA

    2 weeks ago

    Ahmedabad, Gujarat, India Lifelancer Full time

    Job Title: Regulatory Affairs Executive API PHARMA Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Associate Skills:Regulatory legislation, Regulatory Permision, Regulatory Guidelines, Regulatory Inspection, Regulatory Policies, Regulatory Practise and SOP,Company OverviewSuccess Vibrant...

  • Senior Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Synerxia Healthcare Full time

    Job description SYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking forposition in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission . Role and responsibilities 1.Responsible for...

  • Senior Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Synerxia Healthcare Full time

    Job descriptionSYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking for position in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission.Role and responsibilities1.      Responsible...

  • Senior Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Synerxia Healthcare Full time

    Job description SYNERXIA Healthcare Pvt Ltd is engaged into Manufacturing & Exports of Nutraceuticals-Health/Dietary Supplements along with Pharmaceutical Products, is one of the Upstart organization is looking for position in Regulatory Affairs - Emerging / ROW Market for pre-submission and post-submission . Role and responsibilities ...

  • Regulatory Affairs Sr. Manager

    2 weeks ago

    Ahmedabad, Gujarat, India Lifelancer Full time

    Job Title: Regulatory Affairs Sr. Manager Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Director Skills:Regulatory Compliance, FDA Regulations, Quality Assurance, Risk Management, Project Management, Communication Skills, Team Leadership, Problem Solving,Company OverviewBBioMatrix...

  • Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Lifelancer Full time

    Job Title: Regulatory Affairs Executive Job Location: Ahmedabad, Gujarat, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Skills:ROW Market, FDA Guidelines, technical documents, Review skills, Analytic Skills, Dossier Preparation,Company OverviewBioMatrix Healthcare Private Limited, 100% export-oriented...

  • Regulatory Affairs Sr. Manager

    2 weeks ago

    Ahmedabad, Gujarat, India Biomatrix healthcare Full time

    Job DescriptionCompany OverviewBBioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP,...

  • Regulatory Affairs Sr. Manager

    2 weeks ago

    Ahmedabad, Gujarat, India Biomatrix healthcare Full time

    Company OverviewBBioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP, successfully...

  • Regulatory Officer

    2 weeks ago

    Ahmedabad, Gujarat, India United HR Solutions Pvt. Ltd. Full time

    Job Overview:Mid-Level: 4 to 6 years of experience, Full-Time position in AhmedabadQualifications and Skills:Experience in regulatory affairs within the pharmaceutical sectorKnowledge of regulatory frameworks and guidelinesStrong understanding of regulatory documentation and submissionsExcellent communication and problem-solving skillsAbility to work...

  • Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Biomatrix healthcare Full time

    Company OverviewBioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP, successfully...

  • Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Biomatrix healthcare Full time

    Job DescriptionCompany OverviewBioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP,...

  • Only 24h Left: Regulatory Officer

    2 weeks ago

    Ahmedabad, Gujarat, India United HR Solutions Pvt. Ltd. Full time

    Job DescriptionJob Overview:Mid-Level: 4 to 6 years of experience, Full-Time position in AhmedabadQualifications and Skills:- Experience in regulatory affairs within the pharmaceutical sector- Knowledge of regulatory frameworks and guidelines- Strong understanding of regulatory documentation and submissions- Excellent communication and problem-solving...

  • Head of Regulatory Affairs

    7 days ago

    Ahmedabad, Gujarat, India Beeline Capital Advisors Private Limited Full time

    Job Overview:The Head of Compliance is responsible for leading the development and implementation of effective compliance strategies within the merchant banking company. This role involves ensuring adherence to regulatory requirements, internal policies, and ethical standards, thereby mitigating legal and financial risks. The Head of Compliance will work...

  • Tax Regulatory Specialist

    3 days ago

    Ahmedabad, Gujarat, India Aurnex Group Full time

    Aurnex Group is searching for a skilled Tax Regulatory Specialist to manage tax compliance and regulatory affairs. In this position, you will be responsible for managing compliance with U.S. tax regulations and ensuring regulatory compliance for our clients. As a Tax Regulatory Specialist, you will utilize your analytical skills to analyze financial data and...

  • Asst. Manager Regulatory Affairs

    3 weeks ago

    Ahmedabad, Gujarat, India Acme Generics Full time

    Markets to be handled: US, EU, ROW & AfricaCompilation, preparation & review of dossiers in CTD, ACTD formats and country specific as per regulatory guidelines of countries.Active Co-ordination with Inter department (Production, Quality Assurance, Quality Control, Packaging department and F & D) for technical data requirement.Knowledge/Exposure of ICH...

  • Compliance Officer for Alternative Assets

    5 days ago

    Ahmedabad, Gujarat, India Oister Global Full time

    Oister Global is India's premier Alternative Assets Manager, combining robust diligence, deep domain expertise, and an extensive network to create high-quality private market opportunities for our investors. We are seeking a highly skilled and experienced Company Secretary to ensure corporate compliance, governance, and efficient administration of company...