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Regulatory Affairs Specialist

hace 2 meses

Bogotá, Bogotá D.E., Colombia PTC Therapeutics, Inc. A tiempo completo
Regulatory Affairs Manager - SAM Region

The Regulatory Affairs Manager - SAM Region plays a key role in leading the planning and execution of regulatory activities for development, registration, and post-authorization initiatives in the SAM region (South America, Andean Region, and Mexico). Key responsibilities include:

  1. Developing and implementing regulatory strategies to obtain, maintain, and extend product development and registrations in the SAM region.
  2. Providing guidance to internal groups and business partners on technical and regulatory matters, ensuring alignment with senior leadership and current regulations.
  3. Managing the creation and execution of regional regulatory documents for submissions, including Marketing Authorization Applications (MAAs) and Clinical Trial Applications (CTAs).
  4. Acting as the main contact with country Regulatory Agencies, leading agency meeting preparation and attending key meetings to ensure full discussion of issues and opportunities.
  5. Collaborating with Project Management and Regulatory Operations to ensure timely and aligned regulatory submissions across indications and compounds for SAM.
  6. Developing, reviewing, and maintaining Regulatory and company-wide policies and SOPs, ensuring compliance.

Requirements

  • Based in Colombia.
  • Bachelor's degree in a scientific discipline.
  • Advanced degree (PharmD, PhD) in a related area.
  • Significant Regulatory Affairs experience in a pharmaceutical, biotechnology, or related environment.
  • Fluent in English (verbal and written).
  • Proven ability to lead, coordinate, and prepare regulatory submissions in the SAM region.
  • Excellent verbal and written communication skills.
  • Ability to work independently and collaboratively in a fast-paced team environment.

EEO Statement:

PTC Therapeutics is an equal opportunity employer, committed to treating all applicants fairly and avoiding discrimination.