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Bioplus Life Sciences
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Hiring For Regulatory Affairs ROW

Hiring For Regulatory Affairs ROW

Bioplus Life Sciences

8 - 13 years

1 - 6 Lacs

Bengaluru

Posted:1 month ago| Platform:

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Skills Required

Regulatory Affairs Row OSD

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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Hiring For Regulatory Affairs ROW