Hiring For Regulatory Affairs ROW

Roles & Responsibilities:

• Develop and execute regulatory strategies for the registration and lifecycle management of pharmaceutical products in ROW markets.
• Compile, review, and submit high-quality regulatory dossiers (CTD/eCTD format) in compliance with regional authority requirements.
• Interact with local affiliates, regulatory agencies, and distributors to ensure timely approvals and resolve queries or deficiencies.
• Maintain regulatory documentation and product information to ensure compliance with health authority regulations.
• Monitor and analyze changing regulatory landscapes in ROW regions and update stakeholders on impact.
• Support cross-functional teams including R&D, QA, Supply Chain, and Commercial in regulatory matters related to ROW.
• Manage post-approval changes (variations), renewals, and other lifecycle submissions.
• Participate in audits and inspections, ensuring regulatory readiness and compliance.
• Train and mentor junior regulatory staff, if applicable.

EXPERIENCE:

• 8 10 years of experience in Regulatory Affairs in ROW markets.
• Strong knowledge of regulatory guidelines (ICH, WHO, local agency requirements).
• Experience with dossier preparation (CTD/eCTD) and handling agency queries.
• Understanding of regulatory requirements across key ROW territories.
• Project management and stakeholder communication skills.

SKILLS:

• Familiarity with registration processes for both generics and branded formulations.
• Experience in working with third-party manufacturers and CROs.
• Hands-on experience with regulatory tracking tools and systems.