Contractor, Sr. Analyst, Regulatory Affairs

Contractor, Sr. Analyst, Regulatory Affairs -Brazil (Temporary role)

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Contractor, Sr. Analyst, Regulatory Affairs -Brazil (Temporary role)

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PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
Visit our website to learn more about our company and culture
Site: Description
Job Description Summary:
Location: São Paulo, Brazil
Temporary position (contractor)
About The PTC Therapeutics
Founded in 1998, PTC Therapeutics is a global commercial, diversified biopharmaceutical company. Our team is deeply committed to a unifying purpose: Extending life's moments for rare disease patients and their loved ones.
PTC is a science-led, patient-centered biopharmaceutical company focused on discovering, developing and commercializing medicine for patients with orphan diseases.
At PTC, we foster an inclusive culture and are actively seeking diverse, talented individuals to join our team. Visit our website to learn more about our company and culture
Site: Summary
The Contractor, Sr. Analyst, Regulatory Affairs - Brazil collaborates with and executes the regulatory activities for development, registration and post-authorization initiatives in Brazil. Main responsibilities include, but are not limited to: coordinate and execute the generation and completion of regulatory documents for submissions to Brazil region health authorities and support marketing application submissions and their maintenance, 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. The Sr. Analyst, Regulatory Affairs - Brazil works in alignment with the Regulatory, supports adherence to relevant regulatory requirements and company SOPs as appropriate.
Essential Functions

• Collaborates with and executes the development, preparation and implementation of regulatory strategies to obtain, maintain and extend product development and registrations in Brazil;
• 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 leadership; remains knowledgeable about
• current regulations and guidance, internal groups, and business partners, interprets and notifies appropriate personnel;
• Evaluates, creates and completes regional regulatory documents for various submissions, including, but not limited to: post-approval variations, GMP certification and other relevant regulatory filings; prepare forms, cover letters or other administrative components for Brazil regulatory submissions.
• Prepares, review and submits, as applicable, submissions to Municipal and State Health Authorities and Regional Pharmacy Council.
• 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 for Brazil; provides updates and coordinates assigned regulatory submission timelines using the appropriate project management tools.
• Ensures that Regulatory and other company-wide and departmental policies and SOPs are followed.
• Performs Regulatory Intelligence activities, including competitors monitoring and assessments of new regulations.
• Supports emerging department and local business needs as determined by regulatory department leadership, including but not limited to: generation and maintenance of prescribing information and promotional materials.
  

Requirements

• Bachelor's degree in Pharmacy or similar discipline
• Experience in Regulatory Affairs working in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment
• Demonstrated, hands-on experience leading, coordinating and preparing regulatory submissions for small molecules (synthetic) in Brazil.
• Good understanding of Brazil 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.
• Fluent in English (verbal and written).
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  

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.
Click here to return to the careers page Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Legal
• Industries Biotechnology Research and Pharmaceutical Manufacturing

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