Regulatory Affairs Manager

Blackfield Associates • Slough, ENG, United Kingdom • 5h ago

Job Description

Blackfield Associates are partnered with a Pharmaceutical client, seeking a Regulatory Affairs Manager to lead their regulatory activities for both developmental and post-approval projects for a speciality and Generic drug portfolio.

As Regulatory Affairs Manager, you will:

Ensure timely preparation and submission of documents required by the EMA for an EU orphan-registered product.
Manage the registration and maintenance of assigned generic products in coordination with EU compliance requirements.
Provide strategic input for development programs and registration documentation based on regulatory guidelines, with a focus on specialty and generic products.
European Launch Support: Define local regulatory requirements for various EU countries to ensure proper product launches.
Regulatory Compliance: Identify and implement relevant European guidelines for product development and registration.

To be considered for the role of Regulatory Affairs Manager, you will have:

Strong knowledge of EU regulatory requirements for developing strategies for specialty products, particularly for orphan and generic products.
Experience with Innovative Product Development: Significant experience in designing regulatory strategies and managing approval processes for innovative pharmaceutical products, such as inhalation products or complex injectables.
Lifecycle Management: Proven track record in managing Marketing Authorization submissions (DCP, MRP) and post-approval activities such as line extensions and variations.
Product Launch Experience: Solid understanding of market requirements across the EU, ensuring smooth product launches and compliance.
Educated to Degree level or higher in Pharmacy, Life Sciences, or a related field.
Experience using regulatory software including: eCTD, CESP, MHRA portal, Eudralink, Microsoft Office Suite

This is a permanent position, hybrid position based in Slough. Unable to offer sponsorship, applicants must hold full right to work in the UK.