Senior Regulatory Affairs Manager - EU Speciality Medicines

Job title: Senior Regulatory Affairs Manager - EU Speciality Medicine

A global pharmaceutical company is Essex are seeking a Senior Regulatory Affairs Manager. This role will focus on the development of medicinal products in the EU

Responsibilities:

• Manage both centralised and/or decentralised filings of Specialty Respiratory medicinal products in EU
• Ensure that regulatory obligations for marketing authorisations are met and provide a point of contact for EMA or national competent authorities.
• Contribute to discussions with Rapporteurs, CHMP members, EMA officials and representatives of European Competent Authorities to secure timely approvals with advantageous labelling.
• Ensure compliance by providing post-marketing support for existing products in Specialty Respiratory portfolio, including co-ordination and preparation of variations to optimise commercial life of products, development of line extensions, and preparation of licence renewal applications.

Requirements:

• Strong scientific background with at least a BSc degree in life or pharmaceutical/healthcare sciences
• Substantial European regulatory affairs experience, preferably gained in a European-based company.
• Experience in managing both new submissions and maintenance work. Experience in pre-MAA activities, in particular clinical development activities, will be a distinct advantage.
• Specialty experience in the Respiratory therapeutic area is an advantage.
• Thorough knowledge of the fundamental process and requirements in the areas of pre-MAA R&D (clinical in particular), pre-and post-marketing of medicinal products.

Salary and benefits:

A highly competitive salary, annual bonus, private healthcare and winder benefits package is on offer.

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk