Client:
Location:
Viladecans, Spain
Job Category:
Other
EU work permit required:
Yes
Job Views:
2
Posted:
30.04.2025
Expiry Date:
14.06.2025
Job Description:
THE COMPANY
A global pharmaceutical company specialized in supplying high-quality pharmaceutical products to European clients and providing regulatory support, with a product portfolio of over 200 finished dosage forms, including oral solids, liquids, and injectables.
JOB DESCRIPTION
We are seeking a dynamic and experienced Regulatory Affairs professional to join our team as an RA Project Manager. You will manage a range of regulatory activities supporting our third-party operations, including managing submissions via DCP, RUP, duplicates, MA transfers, and variation applications. You will also be involved in pharmacovigilance activities.
KEY RESPONSIBILITIES
• Review MAA dossiers and liaise with the RA department at our headquarters in India.
• Support clients with regulatory and technical information about our products.
• Prepare and submit dossiers to EU health authorities using national and decentralized procedures.
• Follow up on submissions with European health authorities.
• Develop RA strategies and coordinate submissions with European customers.
• Respond to deficiency letters from health authorities.
• Publish eCTD submissions.
• Maintain dossiers, including PSUR submissions, variations, and renewals.
• Stay updated on regulatory requirements in the region.
• Perform pharmacovigilance activities.
• Support quality agreements and product releases.
• Develop and implement SOPs.
Candidate Profile
• Degree in Pharmacy or Life Sciences.
• 3-5 years of experience in Regulatory Affairs within a pharmaceutical company, preferably with generics.
• Experience with European MA procedures (DCPs) and procedures in non-EU European countries, such as Israel, Serbia, and Canada, is advantageous.
• Experience with pharmacovigilance and quality assurance is desirable.
• Experience with eCTD software is a plus.
• Good knowledge of European regulations for medicinal products, GMP, and pharmacovigilance.
• Fluency in English, both written and spoken.
• Proficient computer skills.
Soft Skills
• Excellent communication, teamwork, and organizational skills.
• Flexible, enthusiastic, and customer-oriented.
• Commercial awareness and strategic thinking.
• Autonomous and responsible in task management.
• Assertive decision-making and communication.
Note: If you are not a passport holder of the country for the vacancy, you might need a work permit. For more information, check our Blog. Please apply via the 'Apply now' button; do not provide bank or payment details.
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