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
- 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.
- 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 email@example.com