Senior Director, Regulatory Affairs, Latin America

Crinetics; São Paulo; Presencial; USD 150.000 - 200.000; Tempo integral

Resumo da oferta

Crinetics, a leading pharmaceutical company, is seeking a Senior Director of Regulatory Affairs for Latin America. This role involves strategic planning, managing regulatory submissions, and ensuring compliance with industry standards. The ideal candidate will have extensive experience in human medicine development and fluency in both English and Spanish, contributing to innovative therapies for endocrine diseases.

Qualificações

• 13+ years in human medicine development.
• 7-10 years in Regulatory Affairs.
• Fluency in English and Spanish.

Responsabilidades

• Developing and implementing registration strategies for medicinal products.
• Managing RA budgets and resources.
• Preparing regulatory dossiers (INDs, NDAs, etc.).

Conhecimentos

Regulatory strategy development

Budget management

Compliance with SOPs

Cross-functional collaboration

Leadership

Formação académica

Master's or PhD in life sciences

Descrição da oferta de emprego

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Senior Director, Regulatory Affairs, Latin America

Crinetics, a pharmaceutical company based in San Diego, California, is expanding in Latin America. Join us to help develop therapies for endocrine diseases and tumors, with a focus on innovation and patient-centric culture.

Position Summary:

Note: The candidate must be located in Brazil.

This role reports to the Chief Medical and Development Officer and involves developing and implementing registration strategies for medicinal products in Latin America, overseeing regulatory submissions, and interacting with authorities. The Senior Director will help advance our discovery, development, and commercialization of therapeutics.

Responsibilities include:

1. Strategic planning for the next 2 years
2. Managing RA budgets and resources
3. Ensuring compliance with SOPs and instructions
4. Preparing status reports
5. Collaborating with cross-functional and global teams
6. Creating and implementing regulatory strategies
7. Developing department policies
8. Providing leadership and guidance on global regulatory strategies
9. Communicating complex issues to project teams and stakeholders
10. Managing interactions with FDA and other authorities
11. Preparing regulatory dossiers (INDs, NDAs, etc.)
12. Strategic planning and preparation for regulatory meetings
13. Monitoring industry trends and maintaining external relationships
14. Managing budgets and timelines
15. Training and guiding regulatory staff

Product Development and Lifecycle Management:

1. Formulating submission strategies
2. Ensuring timely registration applications
3. Managing lifecycle for licensed products
4. Ensuring compliance with laws and guidelines
5. Approving clinical trial and product labeling

Education and Experience:

• Master's or PhD in life sciences or related field
• 13+ years in human medicine development, with 7-10 years in Regulatory Affairs, and 10+ years in supervisory roles
• Experience in submitting MAAs in Latin America
• Fluency in English and Spanish
• Knowledge of regulatory processes and orphan drug development

Preferred:

• Advanced degrees such as MBA
• Experience with rare diseases and product launches
• Cross-functional teamwork experience

Travel: Up to 25-40% as required.

Equal Opportunity: Crinetics is an Equal Opportunity Employer, committed to diversity and inclusion.