Remote Regulatory Affairs Planning resource I
REMOTE Northbrook, IL 60062 US
Job Description
ESSENTIAL JOB RESPOSIBILITIES:
1. Leads the development, preparation and implementation of regulatory strategies to obtain, maintain and extend product development and registrations in Latin America. Provides proactive guidance to internal groups and business partners based on technical and regulatory knowledge towards development of strategic and tactical plans.
2. Creates and completes local regulatory documents for various submissions including, but not limited to, MAAs and their maintenance, amendments, renewals and variations, and other relevant regulatory filings. Directs business partners and/or manages preparation of forms, cover letters or other administrative components for submissions.
3. Actively works with project management and Regulatory Operations to ensure appropriate planning, tracking, and alignment of content and timelines for regulatory submissions across indications and compounds for Latin America. Provides updates and manages assigned regulatory submission timelines using the appropriate project management tools.
4. Develops professional relationships with Business Partners staff and acts as main contact with local regulatory agencies directly in coordination with Business Partners; supports agency meeting preparation, and key agency meetings to ensure full discussion of issues and opportunities and tracks key outcomes and commitments.
5. Provides guidance to all appropriate departments to ensure compliance with applicable regulations. Remains knowledgeable about current regulations and guidance, including interpretation of regulations/guidance and notification of appropriate company personnel.
6. Develops, reviews and maintains regulatory and other company-wide and departmental policies and standard operating procedures.
7. Leads the process of development, preparation and implementation of the local prescribing information.
8. Reviews and approves promotional materials for assigned portfolios registered and promoted locally in Latin America.
9. Provides regulatory expertise to Drug Safety teams (e.g., PSUR and PBRER applications, Risk Minimization Plans submissions).
QUALIFICATIONS:
- Bachelors degree in scientific discipline required; advanced degree preferred.
- 3-5 years previous experience in pharmaceutical companies or equivalent.
- 3-5 years previous experience with submissions in Latin America.
- Fluent in Spanish and proficient in English.
- Strong scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development. Recognized as an expert in an aspect of pharmaceutical drug development.
- Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to direct reports and others in the department as needed.
- Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.
- Excellent written and oral communication skills, with writing ability to meet regulatory requirements and standards.
- Ability to communicate effectively with cultural awareness and sensitivity and maintain effective working relationships.
- High integrity with respect to maintenance of proprietary, confidential information.
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