Regulatory Compliance Manager

2 days ago

Kannur, Kerala, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 30,00,000

We are seeking an experienced professional to join our team as a Regulatory Affairs Expert.

Job Title: Regulatory Affairs Specialist

Location: Remote

  • Main Responsibilities:

  • The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.

  • Key qualifications include:

    • Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.

    • Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.

    • Interacted with regulatory authorities during product submissions, inspections, and audits.

    • Developed and maintained regulatory strategies to support new product development and lifecycle management.

    • Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance.

    • Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards.

    • Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development.

    • Assisted in responding to regulatory queries, deficiency letters, and inspection findings.

    • Managed regulatory documentation archives and maintained compliance records for audits and inspections.

About This Role:

This is a unique opportunity for a skilled Regulatory Affairs professional to contribute their expertise to the success of our organization. The successful candidate will have excellent communication skills, be able to work effectively in a team environment, and possess a strong attention to detail.

Requirements:

  • A degree in Life Sciences or a related field.

  • Minimum 5 years of experience in Regulatory Affairs.

  • Strong knowledge of regulatory requirements and guidelines.

  • Excellent communication and interpersonal skills.

  • Ability to work independently and as part of a team.

  • Highly organized and detail-oriented.

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