Regulatory Affairs Manager
3 meses atrás
Regulatory Affairs Manager
Quality Compliance
Quality Compliance is a company of excellence in Life Sciences and one of the largest employers in the Brazilian pharmaceutical sector. We offer opportunities for you to join and grow in your career, which is we are always looking for new talents to join our team and our clientes for contribute to improving the health and well-being of the population.
Position Mission:
Perform regulatory submissions and assessments, ensuring compliance with ANVISA and international standards. Manage submissions in CTD format, including registrations and post-approval variations. Collaborate with various departments and external partners to meet the company's regulatory goals, while maintaining high-quality submissions.
Key Responsibilities and Challenges:
- Prepare and submit regulatory documentation in compliance with ANVISA requirements, including initial registrations and post-approval variations;
- Collaborate with cross-functional teams, such as Quality, PE Labs, and global regulatory partners, to ensure compliance and efficient submissions;
- Manage pharmaceutical equivalence studies and ensure adherence to REBLAS Labs' protocols;
- Oversee and manage regulatory timelines, submission commitments, and agency interactions (e.g., preparing meeting minutes and responding to agency inquiries);
- Ensure all regulatory submissions align with industry standards, policies, and timelines, maintaining a high level of quality;
- Provide regulatory assessments for change management processes and ensure updates comply with regulatory standards;
- Participate in global project management and facilitate regulatory tasks coordination with international teams;
- Support the development of compliant artworks for submissions, ensuring adherence to agency guidelines;
- Perform regulatory assessments and submissions for specific projects, ensuring alignment with company objectives;
- Manage and prioritize regulatory issues, keeping track of commitments and project deadlines;
- Ensure that all relevant procedures for product submissions are up to date and compliant with ANVISA.
Knowledge of Tools and Specific Resources:
- Expertise in regulatory submissions, including CTD format and ANVISA guidelines;
- Proficiency in managing pharmaceutical equivalence studies and related compliance activities;
- Strong knowledge of ANVISA requirements, with practical experience interacting with Quality and Manufacturing Operations teams;
- Advanced communication skills, both written and verbal, for collaborating with local and international teams;
- Familiarity with global regulatory frameworks and submission procedures, with a focus on the Brazilian market;
- Proficiency in project management tools and regulatory tracking systems;
- Experience in handling regulatory change management and agency communication.
Required Education:
Bachelor’s degree in Pharmacy;
Master’s degree in Regulatory Affairs or similar courses;
Certificate in Advanced English
Location:
São Paulo/SP
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