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Regulatory Affairs Specialist
3 semanas atrás
We are seeking a skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for coordinating and executing regulatory activities for development, registration, and post-authorization initiatives in Brazil.
Your main responsibilities will include:
- Coordinating the generation and completion of regulatory documents for submissions to Brazil region health authorities;
- Supporting marketing application submissions and their maintenance;
- Evaluating and ensuring that documentation and submissions are complete and in compliance with relevant health authority requirements, company Standard Operating Procedure (SOPs), and other directives.
You will work cross-functionally with internal departments and external resources on Regulatory Affairs related issues. The successful candidate will work in alignment with the Regulatory department, supporting adherence to relevant regulatory requirements and company SOPs as appropriate.
Key Responsibilities:- 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 leadership;
- 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;
- Prepares, reviews, and submits, as applicable, submissions to Municipal and State Health Authorities and Regional Pharmacy Council;
- Participates 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.
