Deputy Manger / Manager Regulatory Affairs (Biosimilars)

MSN Group; Hyderabad; Sur place; INR 1 200 000 - 1 800 000; Plein temps

Résumé du poste

MSN Group is seeking a Deputy Manager / Manager Regulatory Affairs to lead regulatory strategies for Biosimilars in India and the EU. You will manage CMC documentation, CTD/eCTD dossiers, and regulatory submissions, addressing authority queries and lifecycle management.

You will collaborate closely with R&D, Quality, Manufacturing and Clinical teams, ensuring CDSCO, EMA/EU and ICH requirements are met for biologics products.

Qualifications

• Regulatory affairs experience in biotech/biologics.
• Knowledge of CDSCO, EMA/EU and ICH requirements.
• Experience with CTD/eCTD dossiers and regulatory submissions.

Responsabilités

• Lead regulatory strategy for biosimilars in India and EU.
• Prepare/review CMC documentation and CTD/eCTD dossiers.
• Manage regulatory submissions and respond to authority queries.
• Oversee post-approval lifecycle management.
• Collaborate with R&D, CMC, QA, Clinical, Manufacturing and other teams.

Connaissances

Regulatory Affairs

Biotech/Biologics

Cross-functional collaboration

Regulatory strategy

CTD/eCTD review

Outils

CDSCO knowledge

EMA/EU experience

ICH guidelines

Description du poste

Role & responsibilities

Deputy Manager / Manager Regulatory Affairs | Biotech/Biologics |India & EU

We are looking for an experienced Regulatory Affairs professional to support Biosimilars

Regulatory submissions for the Indian and European markets at the MSN R&D Center.

The incumbent will be responsible for regulatory strategy, CMC documentation, CTD/eCTD dossier preparation/review,

regulatory submissions, authority queries, regulatory intelligence and post-approval lifecycle management.

The role will closely collaborate with R&D, CMC, Analytical Development, Quality, Clinical, Manufacturing and other cross-functional teams. Candidates should possess relevant experience in biotech Regulatory Affairs with strong knowledge of CDSCO, EMA/EU and ICH requirements, particularly CMC and biological product regulations.