Regulatory Affairs Specialist

4 days ago


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

Job Title: Regulatory Affairs Specialist

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Job Description:

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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.

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    • Technical skills: Deep understanding of CDSCO regulations, drug development lifecycle, clinical trials, drug approval process, pharmacovigilance, and soft skills like liaison & negotiation, technical writing, presentation skills, interpersonal skills, critical thinking, problem-solving, and attention to detail.
    • Education: Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
    • Experience: 2-5 years of experience in regulatory affairs (CMC + Operations) or a related field with extensive experience in handling regulatory applications to DCGI, RCGM, KDCD, and other regulatory agencies.
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    Benefits:

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    The ideal candidate will have a strong foundation in regulatory affairs and be able to work effectively in a dynamic environment. The role offers opportunities for growth and development, as well as the chance to make a meaningful impact in the field of biologics and CGT products.

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    Others:

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    This is an exciting opportunity to join a growing organization and contribute to the development of innovative solutions in the life sciences industry.



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