Assistant Manager

Purpose

This strategic position is responsible for managing cross-functional teams and ensuring timely adaptation and submission of U.S.

-developed dossiers for international registrations. The role will coordinate closely with Regulatory Affairs, Business Development, Quality Assurance, Analytical Development, and Supply Chain to align project deliverables with corporate objectives.

We are seeking a dynamic, detail-oriented professional with strong regulatory knowledge and proven project management capabilities to join our team and contribute meaningfully to Rubicon's global growth.

Replacement/New recruitment/Internal transfer   New   Position / Job Title   Assistant Manager   Department   Project Management   Reporting To   Head – Project Management   Location   Thane   Years of Experience   5+ years.
Dosage Form   OSD, Liquid dosage, Nasal spray and API's   

Job Responsibilities / Deliverables

Develop and manage detailed project plans for dossier adaptation and regulatory submissions.
Prepare and monitor project budgets, including quarterly reconciliations.
Coordinate and manage updates related to:
Stability studies (due to packaging changes)
Comparative dissolution studies
Specification changes
Other regulatory and quality-related documentation
Ensure timely and effective communication with internal stakeholders.
Maintain strong relationships with external partners and regulatory agencies.
Conduct regular governance meetings with partners and track action items.
Support annual filings and ensure ongoing product maintenance and compliance.
Addressing the plant analytical issue and support.
Preparation of material budget.
Ensure compliance in the laboratory.
Technical training to team members.
Having good knowledge of regulatory guidelines like US, UK, TGA, EU, ROW etc..
Provide weekly regulatory status updates to the Head of Project Management.
Submit monthly Joint Review Meeting reports for senior management.
Handling the teams with proper guidance to ensure and meet the target timelines.
To review the documents through DMS system and follow the QMS system.
To ensure that the analytical work carried out by team is complying to GLP, regulatory and quality expectations and is audit ready for ensuring superior standard of GLP to meet FDA expectations.

Qualifications & Pre-Requisites

Graduate/Postgraduate in Science,

B. Pharm or M. Pharm; MBA or PMP certification is preferred.
4 - 5 years of experience in regulatory project management for finished pharmaceutical products.
In-depth knowledge of regulatory submission processes for Europe (EMA), UK (MHRA), Canada (Health Canada), Australia (TGA), Brazil (ANVISA) and other regulated markets.
Proficiency in preparing project budgets and financial reconciliations.
Hands-on experience with Microsoft Project (MSP) and MS Excel.
Strong interpersonal and collaboration skills across cross-functional teams.
Excellent verbal and written communication abilities.
Demonstrated ability to manage multiple projects and deliver within tight timelines.