Regulatory Affairs Consultant

21 hours ago

Bengaluru, Karnataka, India Parexel Full time ₹ 12,00,000 - ₹ 36,00,000 per year

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

  • Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets, mainly US and EU.
  • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
  • Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
  • Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage.
  • Experience in handling CMC related health authority queries, and author responses to HA requests.
  • Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.
  • Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
  • Authoring CMC component for marketed products, of Annual Reports, Variations, Renewals in EU (Type IA/IB/II/IAIN), and US and RoW markets.
  • Evaluation of change controls and deviations and identification of required documentation and strategy for EU/US submissions and other markets.
  • Co-ordination with internal and external stakeholders for documentation required for various submissions. Identify quality and/or timeliness issues with source documents, as early as possible.
  • Develop up-to-date knowledge about regulatory guideline updates and applying regulatory requirements and their impact on submissions.
  • Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault.
  • Strong communications skills and ability to guide and mentor team members.
  • Ability to work independently
  • Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.
  • Authoring content of the drug product label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
  • Familiarity with EU Guidelines for QRD / Excipients.
  • Artwork management for countries with label in English.

  • Regulatory Affairs

    3 days ago

    Bengaluru, Karnataka, India Dozee Full time ₹ 40,00,000 - ₹ 1,20,00,000 per year

    Note- Candidates who can join immediately can apply Job Description -Regulatory Affairs- Intern Overview We are seeking a highly motivated and experienced person to join our team Responsibilities:Participate in the development of regulatory submission and approval strategy in multiple countries.Maintain awareness and understanding of new and existing...

  • Regulatory Affairs Executive

    5 days ago

    Bengaluru, Karnataka, India Kerala Ayurveda Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Are you passionate about ensuring regulatory excellence in the world of Ayurveda and nutraceuticals?Kerala Ayurveda Limited is looking for a Regulatory Affairs Executive with 4-6 years of experience to join our growing team in Bangalore. This is a great opportunity to work at the intersection of traditional Ayurvedic wisdom and global compliance standards,...

  • Business Development Executive

    1 week ago

    Bengaluru, Karnataka, India Silmed Scientific - Global Regulatory Affairs Partner Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Company DescriptionSilmed Scientific is a global leader in regulatory affairs, specializing in delivering comprehensive end-to-end regulatory solutions for pharmaceuticals, medical devices, and biosimilars. With expertise in regulatory strategy and successful drug development, the company supports approvals across global markets including Europe, the US,...

  • Head- Regulatory Affairs

    5 days ago

    Bengaluru, Karnataka, India Siemens Healthineers Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job ID473488Posted since13-Oct-2025OrganizationSiemens HealthineersField of workQuality ManagementCompanySiemens Healthcare Private LimitedExperience levelExperienced ProfessionalJob typeFull-timeWork modeOffice/Site onlyEmployment typePermanentLocation(s)Bangalore - Karnataka - IndiaThe Head of Regulatory Affairs will lead the regulatory function for...

  • Regulatory & Liaisoning Affairs Officer

    1 week ago

    Bengaluru, Karnataka, India Enerparc Energy Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job DescriptionAbout Company:Enerparc AG is a global expert in developing, engineering, building, and operating ground mount as well as roof mount photovoltaic (PV) systems. As an EPC contractor, our company has connected over 3400 MW of solar systems to electricity grids. With local presence in all active solar markets like Europe, Middle East & Asia, we...

  • Senior Regulatory Affairs Specialist

    6 days ago

    Bengaluru, Karnataka, India AliveCor Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    AliveCor seeks a Senior Regulatory Affairs Specialist to join this exciting start-up that is changing the face of mobile health. In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction. You will work closely with Quality, Engineering, Product Management, Marketing and...

  • Regulatory Affairs Data Analyst

    3 days ago

    Bengaluru, Karnataka, India Resmed Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Description: Regulatory Affairs Data Analyst (GenAI Focus)About the RoleWe are seeking a Regulatory Affairs Data Analyst with a strong analytics background and a passion for emerging technologies to join our global Regulatory Affairs team. This role blends data analytics, enterprise document intelligence, and generative AI, with a focus on enhancing...

  • Regulatory Affairs Analyst II

    2 weeks ago

    Bengaluru, Karnataka, India Waters Corporation Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    OverviewTheRegulatory Affairs Specialist IIhas primary responsibility for provision ofIn Vitro Diagnosticregulatory support to p repare, execute and maintain regulatory filings including change management, support of post market requirements and support of outside vendors [e.g. license holders, in country representatives].Secondary responsibility would be to...

  • Regulatory Affairs Manager

    3 days ago

    Bengaluru, Karnataka, India Biocon Biologics Limited Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Key Responsibilities:Regulatory Strategy & Planning• Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries.• Ensure alignment with global regulatory strategy and business priorities.• Conduct regulatory risk assessment and provide mitigation strategies...

  • Specialist-Regulatory Affairs CMC

    4 days ago

    Bengaluru, Karnataka, India Clinchoice Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Primary Responsibilities:Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval.Responsible for writing CMC modules 2 & 3.Exposure to EU & CIS region in Regulatory filingsManage and coordinate product life cycle management.Ensure regulatory compliance with local...