Regulatory Affairs Specialist

4 days ago


Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 12,27,167 - ₹ 20,25,328

About this role

Job Summary

This is a unique opportunity to join a global organization as a Regulatory Affairs Executive. You will be responsible for ensuring compliance with regulatory requirements in the Indian market.

The ideal candidate will have a strong understanding of the India MDR and experience in managing regulatory licenses. Additionally, they should have excellent communication skills and be able to work effectively with stakeholders across different time zones.

We offer a collaborative and dynamic work environment that fosters growth and development. Our team is passionate about delivering high-quality solutions and making a positive impact on society.

Key Responsibilities
  • Regulatory Compliance
    • Develop and implement strategies to ensure compliance with regulatory requirements in the Indian market.
    • Collaborate with international teams to understand their evolving business needs.
    • Provide guidance on the India MDR and support the implementation of regulatory compliant processes.
  • Regulatory License Management
    • Manage regulatory licenses and permits for multiple operating companies within the group.
    • Evaluate and recommend technology platforms to streamline license management processes.
  • Stakeholder Engagement
    • Communicate effectively with stakeholders across different time zones.
    • Build relationships with regulatory officers and external consultants to ensure compliance with regulatory requirements.
Requirements
  • Education
    • Degree in Regulatory Management or related field.
  • Experience
    • Minimum 1-3 years of relevant experience in regulatory affairs.
    • Strong knowledge of the India MDR and regulatory license management.
  • Skills
    • Excellent communication and interpersonal skills.
    • Able to work effectively in a fast-paced environment.
Benefits

We offer a competitive salary and benefits package, including health insurance, retirement plan, and paid time off. Our team is passionate about delivering high-quality solutions and making a positive impact on society.



  • Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Regulatory Affairs SpecialistThis role is a great opportunity for individuals with a strong understanding of regulatory affairs and a passion for ensuring compliance. The Regulatory Affairs Specialist will play a critical role in assisting international regulatory teams with navigating evolving business needs in the Indian market.Key...


  • Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Title: Regulatory Affairs Specialist">Job Description:">We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to manage and support regulatory submissions, ensure compliance with global regulatory requirements, and maintain the highest standards of operational excellence in regulatory processes.">Technical skills: Deep...


  • Bengaluru, Karnataka, India Biocon Biologics Full time

    Position SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...


  • Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 80,00,000 - ₹ 2,00,00,000

    Regulatory Affairs Specialist JobThis is a critical role in our organization, responsible for managing and supporting regulatory submissions to ensure compliance with global regulations.The ideal candidate will have a deep understanding of CDSCO regulations, including the Drugs and Cosmetics Act, 1940, and related rules, guidelines, and circulars.Key...


  • Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have expertise in regulatory management and a strong understanding of medical device regulations.About the Role:This is an exciting opportunity for a talented professional to work with our international regulatory...


  • Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time

    Regulatory Affairs ManagerWe are seeking an experienced Regulatory Affairs Manager to oversee and execute all regulatory activities for drug substances and products.


  • Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 8,46,992 - ₹ 12,99,898

    Regulatory Affairs AssociateThis is a critical role that involves providing regulatory support to various departments across the organization. The successful candidate will be responsible for ensuring that all regulatory activities align with business needs.Key Responsibilities:The Regulatory Affairs Associate will be responsible for:Providing regulatory...


  • Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 1,50,00,000

    This role plays a pivotal part in bringing medical devices to market while ensuring ongoing compliance. Key responsibilities include participating on cross-functional teams, developing global regulatory strategies, authoring regulatory submissions, and interacting with regulatory agencies.The ideal candidate will have expertise in product development...


  • Bengaluru, Karnataka, India Merck Specialities Pvt. Ltd. Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Work Your Magic with us Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...


  • Bengaluru, Karnataka, India beBeeRegulatory Full time

    Regulatory Affairs ProfessionalThis role is responsible for leading the development and execution of regulatory strategies and documents in support of clinical trials and product registration.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with relevant regulations and guidelines.Prepare and review regulatory documents,...