
Manager Drug Regulatory Affairs
5 hours ago
Role & responsibilities
- Regulatory Strategy Development:
- Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc.
- Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these regions.
- Identify regulatory pathways for new product launches and lifecycle management of existing products.
- Regulatory Submissions and Approvals:
- Prepare and submit regulatory dossiers for new product registrations, variations, and renewals for injectables across multiple jurisdictions (e.g., Africa, CIS, LATAM).
- Coordinate and manage the submission of regulatory documents (CTDs, eCTDs, dossiers, clinical trial applications) to the relevant health authorities.
- Facilitate communication with health authorities, responding to queries, and ensuring compliance with regulatory timelines.
- Compliance Management:
- Ensure that all pharmaceutical products (particularly injectables) comply with regulatory requirements in target markets across ROW.
- Review product labeling, packaging, and advertising materials to ensure compliance with local regulatory guidelines.
- Manage post-market surveillance requirements, including reporting adverse events (AEs), product recalls, or any regulatory non-compliance in the region.
- Cross-functional Collaboration:
- Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that the products meet regulatory requirements throughout the product development lifecycle.
- Provide regulatory input and support during the product development phase, particularly for injectables, which often require more complex regulatory scrutiny.
- Collaborate with marketing and sales teams to ensure that product claims and promotional activities align with local regulatory requirements.
- Regulatory Intelligence:
- Continuously track and evaluate changes in drug regulations, including GMP (Good Manufacturing Practice), GxP, and other relevant policies across various countries in ROW.
- Act as the internal subject matter expert on regulatory issues related to injectables in ROW markets.
- Monitor competitor activities and regulatory trends in the ROW regions, particularly for injectables.
- Regulatory Affairs Leadership:
- Lead and manage a team of regulatory professionals across the ROW regions, guiding their work in regulatory submissions and compliance activities.
- Provide mentoring and training to team members to enhance their regulatory knowledge and skills, particularly in the injectables segment.
- Risk Management & Problem Solving:
- Identify and mitigate regulatory risks related to the approval process for injectables in target regions.
- Address regulatory challenges or delays and take proactive steps to resolve issues, including negotiating with health authorities or addressing deficiencies in submissions.
- Regulatory Advocacy and Relationship Management:
- Build and maintain strong relationships with key regulatory authorities in various ROW regions, including ministries of health, regulatory bodies, and industry associations.
- Represent the company at regulatory meetings, conferences, and workshops related to pharmaceutical regulations and injectables.
- Documentation & Reporting:
- Maintain accurate and comprehensive regulatory files and documentation for products, especially injectables, in compliance with regional regulations.
- Provide regular updates to senior management on regulatory milestones, challenges, and market access status.
Preferred candidate profile
Must have experience into injectables dosage forms.
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