Executive / Sr. Executive Regulatory Affairs (Europe/UK)

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. UMEDICA's manufacturing facility, located in Vapi (Gujarat), is approved by global regulatory. UMEDICA was founded in 1983 and has business operations in more than 85 countries including the USA, Canada, EU, UK, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.

We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.

As part of our further expansion and growth plans, we are looking to hire an aggressive and dynamic Regulatory Affairs Professional (Executive / Sr. Executive) who will assume the responsibility for the EU & UK Markets specifically for our Finished Formulations Business. UMEDICA currently has 11 products approved and commercialised in the US market and a number of additional products currently under filing / in the development pipeline.

This position is based at our R&D Center at Navi-Mumbai Turbhe and will report into the AGM – Regulatory Affairs (Europe/UK).

The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards.

Position Overview

The Executive/Senior Executive – Regulatory Affairs (EU/UK Market) will be responsible for supporting and managing regulatory activities related to product registration and lifecycle maintenance within the European Union and the United Kingdom. The role involves preparing and submitting dossiers in eCTD/ NeeS formats, coordinating variations and renewals, and ensuring full compliance with EMA and MHRA regulatory requirements.

This position plays a key part in implementing regulatory strategies, ensuring timely submissions, and liaising with cross-functional teams to align global and local regulatory objectives.

Key Responsibilities

- Prepare, review, and submit regulatory dossiers for EU (via MRP/DCP/National) and UK (MHRA) procedures in eCTD format. - Support compilation of quality (Module 3), clinical, and non-clinical documentation as per CTD structure and ICH/EMA/MHRA guidelines. - Manage lifecycle activities, including variations, renewals, and responses to deficiency letters or regulatory queries. - Review and approve product labelling, SmPCs, PILs, and artworks to ensure regulatory accuracy and compliance. - Maintain up-to-date knowledge of EU/UK legislative changes (EU/UK Variations Regulation, Brexit-related MHRA updates, etc.) and communicate regulatory intelligence internally. - Coordinate with formulation, analytical, and quality teams to support data generation and ensure completeness of the registration dossier. - Assist in maintaining regulatory tracking systems, archival of approved dossiers, and management of product licenses. - Provide support during internal or external audits as required by project and compliance needs.

Qualifications

- Bachelor’s or master’s degree in pharmacy. - Minimum 7 years of hands-on experience in regulatory affairs, preferably with EU and/or UK market submissions. - Experience in EU-DCP/MRP procedures, national submissions, and MHRA requirements post-Brexit. - Working knowledge of eCTD publishing, variation classification, and submission tools (e.g., CESP, MHRA Portal). - Familiarity with key regulatory guidelines such as EMA QRD templates, CMDh best practice guidance, and ICH CTD Module requirements.

Skills and Competencies

- Strong understanding of EU/UK regulatory frameworks and submission pathways. - Excellent document review and analytical skills with attention to detail. - Good communication and coordination capabilities for cross-functional teamwork. - Ability to handle multiple projects efficiently within set timelines. - Proficiency in MS Office and regulatory submission software (e.g., eCTD Manager, PharmaReady, Extedo, etc.).