Regulatory Affairs Specialist

1 day ago


India Biocon Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon in US/Canada Market. This role is an exciting opportunity for individuals with experience in formulation regulatory affairs.

Key Responsibilities
  • Prepare, review and submit ANDA/ANDS in the US Market, including modules.
  • Contribute to life cycle management for products filed in the US market.
  • Maintain comprehensive knowledge of regulatory guidelines and requirements.
  • Collaborate with cross-functional teams on product development and manufacturing projects.
  • Ensure compliance with US regulatory submissions.
  • Manage regulatory databases and publish eCTD dossiers as required.
  • Review technical documentation for dossier submission.
Requirements
  • Hands-on experience with ANDA/ANDS filing.
  • Experience working in a pharma company.
  • Strong understanding of US submissions.
  • Proficiency in regulatory guidelines.
What We Offer

This is a full-time position based in Bangalore, India. The ideal candidate will have 7-12 years of experience in a similar role and possess a Master's degree in Pharmacy or Science.

The salary range for this position is approximately ₹20-40 lakhs per annum, depending on qualifications and experience. We offer a competitive package that includes benefits such as medical insurance, retirement plans, and opportunities for professional growth.

Candidates meeting the requirements are encouraged to share their CVs with us. Please mention your total experience, current CTC, number of ANDA/ANDS filings, handling pre-approval activities, and notice period. Additionally, kindly indicate if you are willing to work in Bangalore with a 5-day workweek.



  • India Apsida Life Science Full time

    Apsida Life Science are looking for a Regulatory Affairs Specialist for a long term project.Immediate start!!!You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams.Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia, Singapore...


  • India BioTalent Search Private Limited Full time

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bengaluru. As a key member of our organization, you will play a vital role in ensuring compliance with regulatory requirements and driving the success of our medical device testing business.About Us:BioTalent Search Private Limited is a...


  • india Apsida Life Science Full time

    Apsida Life Science are looking for a Regulatory Affairs Specialist for a long term project. Immediate start!!! You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams. Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia,...


  • india Apsida Life Science Full time

    Apsida Life Science are looking for a Regulatory Affairs Specialist for a long term project.Immediate start!!!You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams.Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia, Singapore...


  • india Apsida Life Science Full time

    Apsida Life Science are looking for a Regulatory Affairs Specialist for a long term project. Immediate start!!! You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams. Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia,...


  • India Apsida Life Science Full time

    Apsida Life Science is seeking a Regulatory Affairs Specialist for a long-term project in the Asia-Pacific region. The ideal candidate will have expertise in regulatory requirements for Vietnam, Philippines, Thailand, Malaysia, Singapore, and other ROW countries.The role involves providing strategic guidance on regulatory compliance, collaborating with...


  • India Qure.ai Full time

    About Qure.AI: Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted...


  • India Qure.ai Full time

    About Qure.AI: Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted...


  • india OMC Medical Limited Full time

    Role Description This is a full-time on-site role for a Regulatory Affairs Associate at OMC Medical Limited. The Regulatory Affairs Associate will be responsible for handling regulatory documentation, ensuring regulatory compliance, understanding regulatory requirements, preparing regulatory submissions, and managing overall regulatory affairs for medical...


  • India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full time

    About Medisal Pharma As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a...


  • India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full time

    About Medisal Pharma As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a significant...


  • India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full time

    About Medisal PharmaAs a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a significant...


  • India Zeon Lifesciences Ltd Full time

    The Regulatory Manager will be responsible for overseeing and ensuring that all food compliance mandates related to FSSAI and AYUSH formulation guidelines are strictly adhered to. This includes managing compliance for Zeon's domestic product range, which covers Proprietary Foods, Nutraceuticals, Health Supplements, Food for Special Dietary Users (FSDU),...


  • India B. Braun Medical Inc. Full time

    **Job Description**: You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping...


  • India Intas Pharmaceuticals Full time

    Job Description:We are seeking an experienced Regulatory Affairs Manager to join our team at Intas Pharmaceuticals. This role will be responsible for preparing and submitting applications and dossiers for registration of recombinant products, CGT products in India, and PCT applications.The successful candidate will have a strong background in pharmaceutical...


  • India Zeon Lifesciences Ltd Full time

    At Zeon Lifesciences Ltd, we're seeking an exceptional Regulatory Compliance Specialist to lead our regulatory operations in the domestic market.About the Role:The successful candidate will be responsible for ensuring strict compliance with FSSAI and AYUSH formulation guidelines for our Proprietary Foods, Nutraceuticals, Health Supplements, Food for Special...


  • india Medical Learning Hub Full time

    Clinical Affairs ManagerJoin the Future of HealthcareTC4A, a pioneer in democratizing healthcare innovations, is revolutionizing diagnostics with LightAI. We are seeking talented individuals to join our office in Noida and address one of healthcare’s biggest challenges, the overuse of antibiotics that leads to drug-resistant infections and costs billions...


  • India Medical Learning Hub Full time

    Clinical Affairs Manager Join the Future of Healthcare TC4A, a pioneer in democratizing healthcare innovations, is revolutionizing diagnostics with LightAI. We are seeking talented individuals to join our office in Noida and address one of healthcare’s biggest challenges, the overuse of antibiotics that leads to drug-resistant infections and costs...


  • india Rubicon Research Limited Full time

    About Rubicon ResearchRubicon Research Limited is a fast-growing pharmaceutical formulations company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.Our product portfolio comprises over 250 SKUs across more than 70 product...


  • India Dozee Full time

    Overview : Include dossier preparation, on-time tracking of applications and network with regulatory bodies and bring in compliance. Play an active role in a change environment Supports the ongoing implementation and sustainment of Quality and Regulatory compliance as per local and international rules and regulations. Responsibilities : Plan,...