Regulatory Affairs Professional

4 days ago

Shimoga, Karnataka, India beBeeCompliance Full time ₹ 1,00,00,000 - ₹ 2,00,00,000
Job Overview:

We are seeking an experienced Regulatory Affairs professional to join our team. As a key member of our regulatory unit, you will be responsible for preparing, reviewing, and submitting regulatory documentation to global health authorities.

Your primary focus will be on ensuring compliance with applicable regulations, including FDA, EMA, CDSCO, MHRA, ISO 13485, and ICH guidelines.

  • You will prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.
  • You will ensure compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices.
  • You will interact with regulatory authorities during product submissions, inspections, and audits.

In addition to your technical expertise, you will have excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.

As a Regulatory Affairs professional, you will stay up-to-date with the latest regulatory changes, guidelines, and industry best practices, ensuring that our organization remains compliant and competitive.

Key Responsibilities:

Preparation and Submission of Regulatory Filings:

• Prepare, review, and submit regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications.

• Evaluate regulatory requirements and develop strategies to ensure compliance.

Regulatory Compliance:

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

Interaction with Regulatory Authorities:

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

Quality Systems Support:

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

About Us:

We are a leading company committed to delivering high-quality products and services. Our team is dedicated to excellence and innovation, and we are looking for talented individuals like you to join us.

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