Sidvim LifeSciences Private Limited
Website:
sidvim.com
Job details:
This position will focus on advisory, regulatory strategy, due diligence, and client-facing problem solving for pharmaceutical and biotech clients. The candidate will work on strategic engagements involving biosimilar feasibility assessment, regulatory pathway design, CMC strategy, portfolio prioritization, and commercialization planning. The role requires cross-functional collaboration with analytical, process development, clinical, CMC, quality, and regulatory teams of the client / target .
1. Advise clients on analytical similarity expectations and comparability strategy.
2. Provide gap assessments for biosimilar programs.
3. Interpret evolving global biosimilar guidance and advise on regulatory impact.
4. Serve as subject matter expert (SME) in biosimilars for consulting engagements.
5. Provide inputs on Portfolio selection& develop competitive landscape analysis
6. Development cost modelling inputs.
7. In Due Diligence & Transaction Support; Evaluate biosimilar asset readiness, Assess CMC development maturity, Identify regulatory risks and approval probability & Support valuation and investment decisions for PE/VC clients.
Qualifications:
1. M. Pharm / MS (Biotech/Pharmaceutics) / M. Tech / PhD
2. 4–5 years of industry experience
Consulting-Specific Competencies
· Strong PowerPoint and business writing skills
· Structured problem solving
· Ability to synthesize complex regulatory data
· Client-facing communication skills
· Commercial acumen (market access, pricing, competitio
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