Regulatory Affairs (Europe / Regulated Market)

Unison Pharmaceuticals; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Unison Pharmaceuticals Pvt. Ltd. in Ahmedabad seeks an Executive/Sr.

Executive/Assistant Manager to lead regulatory submissions for solid oral dosage forms across Europe, US, Canada, Australia. The role requires 6-8 years in regulated markets, ensuring timely dossiers (Module 2-5) in eCTD format, coordinating with multiple departments, and providing regulatory insights for CMOs/CDMOs. You will maintain submission databases, perform change controls assessments, and help develop regulatory CMC

Qualifications

• Minimum 6-8 years of experience in regulated markets for solid oral dosage form.
• Qualification: M. Pharm.
• Experience with eCTD submissions across multiple regions.

Responsibilities

• Author and submit dossiers (Module 2-5) for Europe, Australia, South Africa, New Zealand and Canada in eCTD format.
• Assess change controls and prepare variation packages per timelines.
• Prepare quality responses to deficiency letters from clients/agencies within timelines.
• Coordinate with departments to gather data for dossier and query responses.
• Review source documents for in-house: product development, specs, manufacturing batch records, analytical methods, validation reports.
• Participate in evaluation of regulatory compliance of document/process/test method changes.
• Provide regulatory insights and support for contract manufacturing (CMO/CDMO).
• Perform gap analysis for dossier extension to other territories per country requirements.
• Identify and communicate risks and issues affecting project progression.
• Assist in development of Regulatory CMC strategies; update regulatory submission database.
• Any other regulatory activity as per business needs.

Skills

Regulatory submissions

Dossier preparation

Change controls

Regulatory compliance

Cross-functional coordination

CMC strategy

eCTD publishing

Documentation review

Education

M. Pharm

Job description

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, New 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

Team HR

Unison Pharmaceuticals