Regulatory Professional Lead

5 days ago


Karachi, Sindh, Pakistan Pharmatec Pakistan (Pvt.) Limited Full time
Regulatory Affairs Specialist

Pharmatec Pakistan (Pvt.) Limited is seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for developing and executing regulatory strategies for drug development projects, ensuring compliance with relevant regulations.

Key Responsibilities
  1. Develop and execute comprehensive regulatory strategies for drug development projects, encompassing pre-IND meetings, IND submissions, and NDA/BLA filings.
  2. Prepare and submit high-quality regulatory documents, including new drug applications (NDAs), biologics license applications (BLAs), and amendments.
  3. Act as a liaison between regulatory agencies and our organization to facilitate communication and resolve issues.
  4. Maintain awareness of regulatory guidelines and updates, ensuring adherence to evolving regulations.
  5. Collaborate with cross-functional teams to support regulatory submissions and compliance, including clinical, quality, and manufacturing departments.
  6. Establish and implement regulatory strategies to support product lifecycle management, including labeling and advertising initiatives.
  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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