Company Description

Novalie Pharma is a newly established pharmaceutical company based in Ávila, Spain, specializing in the manufacturing and marketing of pharmaceutical and supplement products. Our mission is to deliver high-quality healthcare solutions to enhance patient outcomes and improve quality of life globally.

Role Description

We are seeking a Regulatory Affairs Specialist to join Novalie Pharma on a full-time, on-site basis. The Regulatory Affairs Specialist will play a crucial role in managing regulatory documentation and ensuring compliance with national and international regulations. The selected candidate will be responsible for preparing and submitting registration files for our products in various countries, directly communicating with regulatory authorities, and ensuring smooth product registrations. This role may require occasional travel.

Key Responsibilities

• Prepare and manage regulatory documentation required for product registration in different markets.
• Ensure compliance with national and international regulatory requirements.
• Stay updated on evolving regulatory guidelines and implement them as needed.
• Directly communicate with regulatory authorities and partners in target countries to ensure timely approvals.
• Organize and submit regulatory filings, including dossiers, renewals, and variations.
• Collaborate with cross-functional teams to gather and align necessary documentation.
• Address and resolve queries from regulatory authorities efficiently.

Qualifications

• Proven experience in regulatory documentation preparation and regulatory submissions.
• Strong understanding of regulatory compliance and regulatory requirements in the pharmaceutical industry.
• Excellent analytical skills and attention to detail.
• Outstanding organizational and time management abilities.
• Effective communicator, capable of managing direct interactions with regulatory bodies across different countries.
• Willingness to travel when required for regulatory meetings or approvals.
• Bachelor's degree in Pharmacy, Life Sciences, or a related field.
• Previous experience in regulatory affairs within the pharmaceutical industry is highly preferred.

Why Join Us?

• Be part of a growing company with a vision to impact global healthcare.
• Gain valuable international experience through direct engagement with regulatory bodies.
• Work in a supportive and collaborative environment that values innovation and excellence.

How to Apply

If you meet the above qualifications and are ready to take on this exciting challenge, we’d love to hear from you! Please contact us directly for further information or Send your CV to [email protected].