Director, Regulatory Affairs

Job Description Summary:
**Job Description**:
Location: Sao Paulo

The incumbent works cross-functionally with internal departments and external resources on Regulatory Affairs related issues.

The Director, Regulatory Affairs supports adherence to relevant regulatory requirements and company SOPs as appropriate.

ESSENTIAL FUNCTIONS
- Leads the development, preparation and implementation of regulatory strategies to obtain, maintain and extend product development and registrations in Brazil; provides proactive guidance to internal groups, and business partners based on technical and regulatory knowledge towards development of strategic and tactical plans.
- 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; directs business partners and/or manages preparation of forms, cover letters or other administrative components for local regulatory submissions.
- Actively works with Project Management and other functions in Regulatory Affairs such as RA CMC, Regulatory Operations and Scientific Writing to ensure appropriate planning, tracking, and alignment of contents and timelines for regulatory submissions across indications and compounds for Brazil; provides updates and manages assigned regulatory submission timelines using the appropriate project management tools.
- Acts as main contact with country Regulatory Agencies directly, or in coordination with local country representation, leads agency meeting preparation, and attends key agency meetings to ensure full discussion of issues and opportunities and to track key outcomes and commitments.
- Provides guidance to all appropriate departments to assure compliance with applicable regulations; remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
- Develops, reviews and maintains Regulatory and other company-wide and departmental policies and SOPs.
- 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 a scientific discipline
- Solid experience working as responsible for Regulatory Affairs experience in a pharmaceutical, biotechnology, CRO or related environment.
- Demonstrated, hands-on experience leading, managing and preparing regulatory submissions in Brazil.
- Ability to routinely accept empowerment from senior leadership to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation.
- Excellent understanding of Brazilian 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 and Portuguese (verbal and written).
- Proficiency with Microsoft Office.
- Excellent verbal and written communication and 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.
- Strong interpersonal relationship skills with an ability to navigate in a global and local team and act as a preferred business parent with commercial and development teams locally and globally
- Excellent leadership skills as well as planning, organization, and time management skills including the ability to support and prioritize multiple projects.

EEO Statement: