Unison Pharmaceuticals, one of the fastest growing organization is looking for below profile:

- Designation: Executive/ Sr. Executive / Assistant Manager
- Job Location: Vastrapur Office, 2nd and 4th Saturday Off
- Qualification: M. Pharm
- Experience: Minimum 6-8 years experience in regulated markets for solid oral dosage form (Europe, US, Canada, Australia).

Roles and Responsibilities Work on variety of Regulatory related submissions including but not limited to the following functions:

- Ensure timely authoring and submission of dossiers (Module 2-5) for regulated regions such as Europe, Australia, South Africa, Recent Zealand and Canada in the eCTD format including familiarity with publishing activities.
- Assessment of change controls, defining the correct variation code and preparation of the variation packages as per the agreed timelines.
- Preparation of quality responses to the deficiency letters from various Clients/agencies within agreed time frame.
- Co-ordinate with various departments to obtain essential scientific data and documents required for dossier preparation and query responses.




- Involve in review of source documents for in-house: product development report, specification (excipients, API and finished product), manufacturing batch record, analytical method,

validation report, validation protocol etc.
- Actively participate in the evaluation of regulatory compliance of document/product/ process/test methods changes.
- Provide regulatory insights and support for contract manufacturing projects (CMO/CDMO).
- Preform gap analysis for extension of dossier to other territories as per country specific requirements.
- Identifies and communicates risks and issues impacting project progression.
- Assist in the development of Regulatory CMC strategies for assigned products and projects.
- Update/Maintenance of database with regulatory submission and approval.
- Any other regulatory activity as per the business needs

Interested candidates may also email their resume to [email protected]

Team HR

Unison Pharmaceuticals

📌 Regulatory Affairs (Europe / Regulated Market) (Ahmedabad)
🏢 Unison Pharmaceuticals
📍 Ahmedabad