Assistant Manager​/Manager - Regulatory Affairs

Sentiss Pharma is committed to providing best quality pharmaceutical products primarily in the Ophthalmic, ENT and Inhalation segments. Sentiss’ presence in India, Russia, CIS, UA, Europe, USA is a testimony to its quality philosophy and practice of product differentiation. Sentiss acquired Akorn AG in 2023, which has a USFDA approved plant that is expected to further increase Sentiss’ presence in the US and European markets and diversify our product range.

Well-built quality systems, compliance to processes, robust business strategies and strong corporate governance have led Sentiss today to rank in the top two ophthalmic companies in Russia, Kazakhstan and Kyrgyzstan. Sentiss has a quality workforce of around 1200 people across multiple geographies. Sentiss is recognized as Great Place to Work in India for 9 years in a row.

JOB RESPONSIBILITIES:

Key Responsibilities:

- Manage ANDA compilation, review & submission, including Controlled Correspondence and Scientific Packages.
- Provide regulatory pathway guidance during development.
- Handle USFDA queries and ensure timely responses.
- Manage post‑approval changes and filing strategy (CBE‑0, CBE‑30, PAS).
- Review DMFs, PDRs, labeling, and technical documentation.
- Oversee establishment registration, re‑registration, and annual updates.

Skills Required

- Hands‑on USFDA filing experience for the US market.

- Experience with sterile dosage forms: injectables, ophthalmic, inhalation.
- Strong PDR and documentation review skills.
- Excellent written & verbal English communication.
- Exposure to Health Canada or EMA submissions.

Qualification

- M.Pharm from reputed institutes.
- 5-8 years of experience in regulated markets.