Regulatory Affairs

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.

We are looking for a dynamic and experienced Regulatory Affairs professional to join our team.

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.

Aptitudes y conocimientos deseados:
THE PROFILE - Valuable education to a degree level in Pharmacy or a Life Science. - 3 to 5 years of experience in the Regulatory Affairs Department of a pharmaceutical company, preferably with generic medicinal products. - Experience with European MA procedures (DCPs) will be an asset. - Experience with procedures in European Non-EU countries, such as Israel, Serbia, and Canada, will be an asset. - Experience with Pharmacovigilance and Quality Assurance will be an asset. - Experience with eCTD software will be an asset. - 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 a user level. THE SOFTSKILLS - Effective teamwork, with excellent communication and good organizational 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. - Commercial vision, with the ability to understand business needs and align regulatory strategies accordingly. - Autonomy in handling tasks and taking ownership of responsibilities. - Assertiveness in decision-making and communication, ensuring clear and confident interactions.