Regulatory Affairs Expert

5 days ago


Vadodara, Gujarat, India Acme Generics Full time

We are seeking a highly skilled Regulatory Affairs Officer to join our team at Acme Generics. As a key member of our regulatory department, you will be responsible for ensuring compliance with regulatory guidelines and requirements for the registration of pharmaceutical products.

Job Summary:

The successful candidate will have experience in compilation, preparation, and review of dossiers in CTD, ACTD formats, and country-specific regulations. You will work closely with our production, quality assurance, quality control, packaging, and research and development teams to ensure seamless technical data exchange.

Responsibilities:
  • Compilation, preparation, and review of dossiers in CTD, ACTD formats, and country-specific regulations
  • Active coordination with cross-functional teams for technical data requirements
  • Knowledge/exposure of ICH Guidelines (QSEM) required for Common Technical Document (CTD) registration of pharmaceuticals
  • Preparation and review of SmPC, Package Insert, and labeling information
  • Online application filing for dossier submission in the US
  • Handling client and MOH queries as per received guidelines

In this role, you will play a critical part in ensuring that our products meet the highest standards of quality and regulatory compliance. If you have a strong background in regulatory affairs and are passionate about delivering high-quality results, we encourage you to apply for this exciting opportunity.

About Us:

Acme Generics is a leading provider of generic pharmaceuticals, committed to delivering innovative solutions to meet the evolving needs of healthcare professionals and patients worldwide. We are driven by our mission to improve patient outcomes through the development and commercialization of high-quality medicines.

Salary Estimate:

We offer an attractive salary package commensurate with your experience and qualifications, including a base salary of approximately $80,000-$100,000 per year, depending on location and performance.



  • Vadodara, Gujarat, India Lifelancer Full time

    Company OverviewRenown Pharmaceuticals Pvt. Ltd., a renowned soft gelatin contract manufacturer, boasts a state-of-the-art facility in India.Job OverviewWe seek an experienced Regulatory Affairs Officer for our Vadodara office. This full-time position requires 1-3 years of experience. The salary range is competitive. Our company has over 200 employees and...


  • Vadodara, Gujarat, India Lifelancer Full time

    About the Role:We are seeking an experienced Regulatory Affairs professional to join our team in a full-time capacity. The ideal candidate will have a strong background in regulatory affairs, specifically within the pharmaceutical industry.Key Responsibilities:Ensure compliance with regulatory requirements for pharmaceutical products in target marketsPrepare...


  • Vadodara, Gujarat, India Lifelancer Full time

    About the CompanyLifelancer is a leading talent-hiring platform in Life Sciences, Pharma and IT, connecting professionals with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Job OverviewWe are seeking a highly skilled Regulatory Affairs professional to join our team in Vadodara on a full-time basis. The ideal...


  • Vadodara, Gujarat, India Lifelancer Full time

    Job OverviewWe are seeking a seasoned Regulatory Affairs professional to join our team in Vadodara on a full-time basis. The ideal candidate will have a strong background in regulatory affairs, specifically within the pharmaceutical industry, and will hold relevant qualifications such as a B.Pharm or M.Pharm degree.Key ResponsibilitiesEnsure compliance with...


  • Vadodara, Gujarat, India Lifelancer Full time

    Job Title: Regulatory Affairs Officer - Global Compliance ExpertAt Renown Pharmaceuticals Pvt. Ltd., we are seeking a highly skilled Regulatory Affairs Officer to join our team in Vadodara, India. This is a full-time position for candidates with 1-3 years of experience.The ideal candidate will have excellent communication skills, the ability to interpret...


  • Vadodara, Gujarat, India Lifelancer Full time

    About UsLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect professionals with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Job Overview:We are seeking a highly skilled Regulatory Affairs professional to join our team on a full-time basis in Vadodara. The ideal candidate will have a...


  • Vadodara, Gujarat, India Lifelancer Full time

    About Lifelancer, a leading talent-hiring platform in Life Sciences and IT.We are seeking an experienced Regulatory Affairs Executive to join our team.The ideal candidate will have 1-3 years of experience in quality control regulatory affairs, with a strong understanding of medical device rules and regulations.A bachelor's or master's degree in life sciences...


  • Vadodara, Gujarat, India Lifelancer Full time

    About LifelancerLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT that connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Job OverviewWe are seeking a highly skilled Regulatory Affairs professional to join our team in Vadodara on a full-time basis. The ideal candidate will have...


  • Vadodara, Gujarat, India Lifelancer Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Officer to join our team at Renown Pharmaceuticals Pvt. Ltd. in Vadodara, India.This is a full-time position for candidates with 1-3 years of experience, offering a competitive salary and opportunities for growth in a dynamic company.About the CompanyRenown Pharma is a reputable soft gelatin...


  • Vadodara, Gujarat, India Lifelancer Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Officer to join our team at Renown Pharmaceuticals Pvt. Ltd. in Vadodara, India.This is a Full-Time position for candidates with 1-3 years of experience, offering a competitive salary range and an opportunity to work with a leading soft gelatin contract manufacturer.


  • Vadodara, Gujarat, India SUN PHARMA Full time

    Company OverviewSun Pharma is a leading pharmaceutical company that offers a wide range of products and services.Job DescriptionWe are seeking an experienced Regulatory Affairs Manager to join our team in Baroda. The successful candidate will be responsible for managing the regulatory affairs function, including ensuring compliance with relevant regulations...


  • Vadodara, Gujarat, India Lifelancer Full time

    Company OverviewRenown Pharmaceuticals Pvt. Ltd. is a renowned contract manufacturer of soft gelatin capsules with a state-of-the-art facility in India.Job OverviewA competitive full-time position for experienced professionals seeking challenging roles in regulatory affairs. The ideal candidate will have 1-3 years of experience and be passionate about...


  • Vadodara, Gujarat, India Sunbuy Renewables Private Limited Full time

    Job Title: Solar Regulatory Affairs SpecialistAt Sunbuy Renewables Private Limited, we are seeking an experienced Renewable Energy Liaison Expert to join our team. This role is responsible for overseeing all regulatory affairs related to solar projects, including government liaisoning, project approvals, and compliance.Responsibilities:Government &...


  • Vadodara, Gujarat, India SUN PHARMA Full time

    Job Summary:We are seeking an experienced Regulatory Affairs Manager to join our team at Sun Pharmaceutical Industries Ltd. in Vadodara, India.This is a challenging role that requires strong knowledge of regulatory submissions and experience in managing teams to ensure compliance with Indian regulations.About the Role:Evaluate regulatory strategies for...


  • Vadodara, Gujarat, India Acme Generics Full time

    Job DescriptionAcme Generics is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. This role involves ensuring compliance with regulatory guidelines and managing technical data requirements.Key Responsibilities:We are looking for an individual who can compile, prepare, and review dossiers in CTD, ACTD formats, and...


  • Vadodara, Gujarat, India Acme Generics Full time

    Join Acme Generics as a Generic Regulatory Affairs Specialist in our dynamic team. As a key member, you will be responsible for the compilation, preparation and review of dossiers in CTD, ACTD formats and country specific regulatory guidelines.About the RoleYou will be working closely with cross-functional teams such as Production, Quality Assurance, Quality...


  • Vadodara, Gujarat, India SUN PHARMA Full time

    About UsSun Pharma is a leading global pharmaceutical company with a presence in over 100 countries.Job OverviewWe are seeking an experienced Biotech Project Manager - Bioanalytical Expert to join our team. This role will be responsible for managing and coordinating bioanalytical projects from start to finish, ensuring timely completion and high-quality...


  • Vadodara, Gujarat, India SUN PHARMA Full time

    Job SummarySUN PHARMA is seeking a highly skilled Remediation and Compliance Expert to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality and compliance across our operations.About the RoleWe are looking for an experienced professional with a strong background in GMP requirements,...

  • Internal Audit Expert

    1 month ago


    Vadodara, Gujarat, India Saaki Argus & Averil Consulting Full time

    Job Title: Internal Audit ExpertWe are seeking an experienced Internal Audit Expert to join our team at Saaki Argus & Averil Consulting.Estimated Salary: ₹1,200,000 - ₹1,800,000 per annumAbout Our ClientSaaki Argus & Averil Consulting is a leading consulting firm that provides engineering research and development services. Our client has a strong...


  • Vadodara, Gujarat, India Krayr Solutions Full time

    Job OverviewKrayr Solutions is seeking an experienced Costing Expert to join our team in Savli Vadodara location.About the RoleThe successful candidate will be responsible for product costing, batch costing, and appropriate overhead allocation. They should be able to establish, upgrade, or enhance the costing system and process within the organization,...