Regulatory Affairs Specialist

hace 2 semanas

Bogotá, Bogotá D.E., Colombia PTC THERAPEUTICS A tiempo completo
Job Description Summary:

Job Title: Contractor, Manager, Regulatory Affairs

Location: Colombia

We are seeking a highly skilled Regulatory Affairs professional to collaborate with our team in leading the planning and execution of regulatory activities for development, registration, and post-authorization initiatives in the South America, Andean Region, and Mexico (SAM) region.

Key Responsibilities:
  • Lead the generation and completion of regulatory documents for submissions to SAM region health authorities.
  • Support marketing application submissions and their maintenance and variations, ensuring compliance with relevant health authority requirements, company Standard Operating Procedure (SOPs), and other directives.
  • Collaborate with internal departments and external resources on Regulatory Affairs related issues.
  • Support adherence to relevant regulatory requirements and company SOPs as appropriate.
Essential Functions:
  • Develop, prepare, and implement regulatory strategies to obtain, maintain, and extend product development and registrations in the SAM region.
  • Provide guidance to internal groups and business partners on technical and regulatory knowledge towards development of strategic and tactical plans.
  • Manage the creation and execution of regional regulatory documents for various submissions, including Marketing Authorization Applications (MAAs) and Clinical Trial Applications (CTAs).
  • Act as main contact with country Regulatory Agencies directly or in coordination with local country representation, leading agency meeting preparation and attending key agency meetings.
  • Work with Project Management and Regulatory Operations to ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across indications and compounds for SAM.
  • Develop, review, and maintain Regulatory and other company-wide and departmental policies and SOPs, ensuring they are followed.
Requirements:
  • Be based in Colombia.
  • Bachelor's degree in a scientific discipline.
  • Advanced degree (Ph.D.) in a related area.
  • Solid Regulatory Affairs experience in a pharmaceutical, biotechnology, contract research organization (CRO), or related environment.
  • Experience in specialized products would be a plus.
  • Fluent in English (verbal and written).
  • Project management experience.
  • Demonstrated, hands-on experience leading, coordinating, and preparing regulatory submissions in the SAM region.
  • Ability to routinely accept empowerment from senior leadership to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation.
  • Good understanding of SAM regulatory requirements and emerging regulatory landscape.
  • Proven ability to read, analyze, and interpret scientific and technical information, as well as regulatory documents.
  • Experienced in responding to inquiries or complaints from regulatory agencies.
  • Proficiency with Microsoft Office.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status, or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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