Regulatory Strategy Coordinator Lead
hace 23 horas
Pfizer is committed to excellence in the field of regulatory affairs. As a key member of our team, you will play a vital role in ensuring compliance with local and international regulations.
Key Responsibilities:
- Participate in the development and implementation of regulatory strategies for product submissions and lifecycle management.
- Coordinate and execute activities related to dossier planning and submission - paper and/or electronic - for initial registration and maintenance of drug products.
- Interact with internal stakeholders to ensure the execution of regulatory strategies according to plan, facilitating business continuity.
- Support senior managers in defining and executing regulatory strategies for assigned portfolios.
- Collaborate across regions to deliver efficiencies in regulatory submissions and processes.
Requirements:
- Understand local market regulatory requirements and processes.
- Coordinate activities related to drug product submissions and license maintenance to health authorities.
- Work in partnership with country regulatory teams and stakeholders to ensure the development and implementation of regulatory strategies.
- Maintain awareness of local regulations and trends.
- Ensure timely updates of regulatory information on Pfizer systems and databases.
- Review submission-ready dossiers to ensure compliance with local regulatory requirements.
- Support bidding processes by providing updated regulatory documents.
- Evaluate and stay informed about BoH regulations and changes.
- Review and approve promotional materials to ensure compliance with SOPs and local requirements.
- Collaborate with labeling and artworks approval processes according to Pfizer procedures and local regulations.
- Complete departmental training to address corporate and regulatory needs.
Qualifications:
- Pharmacist graduate or life science degree.
- Local regulatory experience.
- Minimum 4 years of experience as a Regulatory Affairs Analyst (Human Medicinal Products).
- Proven ability to consistently deliver on time and quality standards.
- Proven ability to manage complex regulatory issues.
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