Regulatory Affairs Pharma

• Generics
• International RA

Multinational Generic Pharmaceutical Company

• 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.

• Contract of Employment: full-time permanent position.


• Benefits package (health insurance, ticket restaurant, complimentary fruit/coffee/snacks).


• Hybrid work model: 1 day/week of home office.


• Flexible schedule.


• Young, positive team culture & engaging interactions within a multicultural team.


• Teambuilding activities.

• Education to a degree level in Pharmacy or a life science.


• At least 5 years' experience in the Regulatory Affairs Department of a pharmaceutical company, preferably with generic medicinal products.


• Experience with European MA procedures (DCPs) will be valued.


• Experience with procedures in European Non-EU countries, i.e. Israel, Serbia & Canada will be valued.


• Experience with Pharmacovigilance and Quality Assurance will be valued.


• Experience with eCTD software will be valued.


• Good knowledge of current European regulations on the registration of medicinal products. Knowledge of GMP and Pharmacovigilance is a plus.


• Fluency in English, both written and spoken. Computer skills at user's level.


• Effective teamwork, with excellent communication and good organization skills; a flexible and enthusiastic approach to work, using your knowledge to solve technical issues. A customer-friendly attitude and the ability to meet demanding deadlines are also essential.