Office based position - Sao Paulo
The Specialist, Regulatory Affairs - Latin America (LATAM) collaborates with and executes the regulatory activities for development, registration and post-authorization initiatives in LATAM region (including Brazil and other countries as identified). Main responsibilities include, but are not limited to: coordinate and execute the generation and completion of regulatory documents for submissions to LATAM region health authorities and support marketing application submissions and their maintenance and variations, and ensure that documentation and submissions are complete and in compliance with relevant health authority requirements (e.g., National Health Surveillance Agency Brazil (ANVISA)), company Standard Operating Procedure (SOPs), and other directives.
The incumbent works cross-functionally with internal departments and external resources on Regulatory Affairs related issues.
- Collaborates with and executes the development, preparation and implementation of regulatory strategies to obtain, maintain and extend product development and registrations in LATAM region;
- Provides guidance to all appropriate departments internal groups, and business partners based on technical and regulatory knowledge towards development of strategic and tactical plans, in alignment with the senior leadership; remains knowledgeable about current regulations and guidance, internal groups, and business partners interprets and notifies appropriate personnel;
- Creates and completes regional regulatory documents for various submissions, including, but not limited to: Marketing Authorization Applications (MAAs) and Clinical Trial Applications (CTAs) and their maintenance, amendments, and variations, and other relevant regulatory filings; prepare forms, cover letters or other administrative components for LATAM regulatory submissions.
- Acts as backup contact with country Regulatory Agencies directly, or in coordination with local country representation; participate in agency meeting preparation and attends key agency meetings to ensure full discussion of issues and opportunities and to track key outcomes and commitments.
- Works 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 LATAM; provides updates and coordinates assigned regulatory submission timelines using the appropriate project management tools.
- Bachelor’s degree in a scientific discipline.
- Minimum of 3-4 years’ experience in Regulatory Affairs in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.
- Advanced English, both written and verbally is a must
- Basic-intermediate Spanish
- Hands-on experience leading, coordinating and preparing regulatory submissions
PTC is a science-led, patient-centered biopharmaceutical company focused on discovering, developing and commercializing medicine for patients with rare disease. For more information on the company, please visit our website www.ptcbio.com
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.