Manager Drug Regulatory Affairs

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.