Drug Development Manager

5 days ago


Karachi, Sindh, Pakistan Pharmatec Pakistan (Pvt.) Limited Full time
Company Overview

Pharmatec Pakistan (Pvt.) Limited is a leading pharmaceutical company committed to providing innovative solutions for healthcare. We are dedicated to delivering high-quality products and services that meet the needs of our customers.

Job DescriptionRegulatory Affairs Specialist

The successful candidate will be responsible for developing and executing regulatory strategies for drug development projects, ensuring compliance with relevant regulations. This includes preparing and submitting high-quality regulatory documents, acting as a liaison between regulatory agencies and our organization, and maintaining awareness of regulatory guidelines and updates.

Key Responsibilities:
  1. Develop and execute comprehensive regulatory strategies for drug development projects.
  2. Prepare and submit high-quality regulatory documents, including NDAs, BLAs, and amendments.
  3. Act as a liaison between regulatory agencies and our organization.
  4. Maintain awareness of regulatory guidelines and updates.
  5. Collaborate with cross-functional teams to support regulatory submissions and compliance.
  6. Establish and implement regulatory strategies to support product lifecycle management.
  7. Conduct thorough regulatory impact assessments and provide recommendations to senior leadership.
  8. Ensure accurate and up-to-date records of regulatory submissions and communications are maintained.
Requirements
  • Must have experience in regulatory affairs and compliance.
  • Must be able to work independently and collaboratively as part of a team.
  • Must be able to maintain confidentiality and handle sensitive information.
  • Must be able to work under pressure and meet deadlines.


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