THE COMPANY

A global pharmaceutical company specialized in supplying high-quality pharmaceutical products to European clients and providing regulatory support, backed by a comprehensive and continuously growing product portfolio of over 200 finished dosage forms, including oral solids, liquids, and injectables.

JOB DESCRIPTION

We are looking for a dynamic and experienced Regulatory Affairs professional to join our team.
As an RA Project Manager, you will be responsible for a wide range of regulatory activities to support our company’s third-party operations. Your responsibilities will include managing and coordinating new submissions via DCP, RUP, duplicates, MA transfers, and variation applications. Additionally, you will be directly involved in certain pharmacovigilance activities.

KEY RESPONSIBILITIES

• Reviewing Marketing Authorization Application (MAA) dossiers and liaising with the RA department at the company’s headquarters in India.
• Supporting existing and potential clients with regulatory/technical information about company products.
• Preparing and submitting dossiers to health authorities in EU countries using national and decentralized procedures.
• Contacting European health authorities to follow up on submissions.
• Communicating with European customers to develop RA strategies and coordinate submissions.
• Reviewing and submitting response documents to deficiency letters from health authorities.
• eCTD publishing.
• Ensuring proper maintenance of dossiers, including PSUR submissions, variations, and renewals.
• Keeping up to date with the latest regulatory requirements in the region.
• Performing selected pharmacovigilance activities.
• Providing support for the development of quality agreements and product release.
• Proposing, developing, and implementing new standard operating procedures.