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
1. Reviewing Marketing Authorization Application (MAA) dossiers and liaising with the RA department at the company’s headquarters in India.
2. Supporting existing and potential clients with regulatory / technical information about company products.
3. Preparing and submitting dossiers to health authorities in EU countries using national and decentralized procedures.
4. Contacting European health authorities to follow up on submissions.
5. Communicating with European customers to develop RA strategies and coordinate submissions.
6. Reviewing and submitting response documents to deficiency letters from health authorities.
7. eCTD publishing.
8. Ensuring proper maintenance of dossiers, including PSUR submissions, variations, and renewals.
9. Keeping up to date with the latest regulatory requirements in the region.
10. Performing selected pharmacovigilance activities.
11. Providing support for the development of quality agreements and product release.
12. Proposing, developing, and implementing new standard operating procedures.
THE PROFILE
1. Valuable education to a degree level in Pharmacy or a Life Science.
2. 3 to 5 years of experience in the Regulatory Affairs Department of a pharmaceutical company, preferably with generic medicinal products.
3. Experience with European MA procedures (DCPs) will be an asset.
4. Experience with procedures in European Non-EU countries, such as Israel, Serbia, and Canada, will be an asset.
5. Experience with Pharmacovigilance and Quality Assurance will be an asset.
6. Experience with eCTD software will be an asset.
7. Good knowledge of current European regulations on the registration of medicinal products. Knowledge of GMP and Pharmacovigilance is a plus.
8. Fluency in English, both written and spoken. Computer skills at a user level.
9. 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.
10. Commercial vision, with the ability to understand business needs and align regulatory strategies accordingly.
11. Autonomy in handling tasks and taking ownership of responsibilities.
12. Assertiveness in decision-making and communication, ensuring clear and confident interactions.
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