Sr Specialist, Regulatory Affairs

Job Description Summary:
**Job Description**:
The Sr. Specialist, Regulatory Affairs (SAM region) collaborates with and executes the regulatory activities for development, registration and post-authorization initiatives in SAM region.

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

The Sr Specialist, Regulatory Affairs - SAM region 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 SAM region;
- 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 senior leadership; remains knowledgeable about current regulations and guidance, internal groups, and business partners interprets and notifies appropriate personnel;
- 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; prepare forms, cover letters or other administrative components for SAM regulatory submissions.
- Acts as backup contact with country Regulatory Agencies directly, or in coordination with local country representation; 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 across indications and compounds for SAM; 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.
- 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.
- Advanced degree (PharmD, PhD.) on a related area (desirable)
- Regulatory Affairs experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.
- Be based in Bogotá (Colombia).
- Demonstrated, hands-on experience leading, coordinating and preparing regulatory submissions in SAM region.
- Ability to routinely accept empowerment from senior leadership to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation.
- Good understanding of SAM 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 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.

EEO Statement: