Job Description

Bioplus Life Sciences is hiring Deputy Manager – Regulatory Affairs for ROW Market
Interested candidates are requested to apply to talent@bioplus.in

Subject : Application for Deputy Manager – Regulatory Affairs (ROW)

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

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