Regulatory Affairs Project Manager (Pharma Industry)

Regulatory Affairs Project Manager (Pharma Industry)

Regulatory Affairs Project Manager (Pharma Industry)

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Regulatory Affairs Project Manager / Job Description

Company description :

Hetero Europe is a generic pharmaceutical company, founded in 2010 and based in Viladecans, as a B2B subsidiary of Hetero, a global pharmaceutical company headquartered in Hyderabad, India. We specialize in supplying high-quality generic pharmaceutical products to our European clients, as well as providing Regulatory support, embraced by our comprehensive and continuously growing product portfolio of over 200 products of finished dosage forms of oral solids, liquids, and injectables.

Position : Regulatory Affairs Project Manager

Experience : Mid-senior level

Job Function : Regulatory

Employment type : Full-Time

Location : Viladecans Business Park – 08840 Viladecans (Barcelona)

Hetero Europe is looking for a dynamic and experienced Regulatory Affairs professional to join our team, with an expected start date in April 2025.

As an RA Project Manager, you will be responsible for a wide range of regulatory activities to support our company’s third-party activities. Your responsibilities will include managing and coordinating new submissions via DCP, RUP, duplicates, MA transfers and variation applications. In addition, you will be directly involved in some pharmacovigilance activities.

Key responsibilities and accountabilities :

• Reviewing Marketing Application Authorization (MAA) dossiers and liaising with the RA department at the company Headquarters in India.
• Supporting existing and potential clients with regulatory / technical information on Hetero´s 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.
• Contacting European customers to elaborate RA strategies and coordinate submissions.
• Reviewing and submitting response documents to deficiency letters of Health Authorities.
• eCTD publishing.
• Ensuring adequate maintenance of the dossiers : PSUR submissions, variations, renewals...
• Keeping up to date with the latest regulatory requirements in the region.
• Performing selected pharmacovigilance activities.
• Providing support for the elaboration of quality agreements and for product release.
• Proposing, elaborating and implementing new standard operation procedures.

Desired Skills and Expertise :

What we offer :

If you’re interested, please submit your CV in English, along with your salary expectations and availability to start.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Project Management and Information Technology

Pharmaceutical Manufacturing

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