Regulatory Manager - advanced therapies and next generation biopharmaceuticals

Regulatory Affairs Manager

Location - East Midlands / Home based

Salary - Open 

This company  is a recognized market-leading developer of  solutions for advanced therapies and next generation biopharmaceuticals

We are seeking a pragmatic and experienced regulatory professional to join us as Regulatory Affairs Manager to oversee regulatory documentation, regulatory strategy and customer support pertaining to regulatory issues 

. You’ll be exceptionally organized and have comprehensive knowledge of biological and biotechnological processes and product development, GMP requirements and global registration procedures. The role will involve interacting with regulatory authorities as well as supporting users of company's offerings worldwide with their product registrations.

As you’ll be interacting with colleagues at all levels across the business and with external stakeholders, you’ll need strong interpersonal and communication skills. High attention to detail will be a key requirement and you will be comfortable making sense of complex, high quantity and sometimes contradictory information to effectively solve problems.

We value our people and are especially proud of our collaborative and friendly culture, based on our values of being Strong, Flexible and Supportive. We continually strive to provide opportunities for our employees to learn, develop and be rewarded.

KEY RESPONSIBILITIES • Overseeing the submission and maintenance of regulatory filings.
• Authoring  product regulatory dossiers in compliance with appropriate standards and guidance for biotech/biological products.
• Conducting interactions with regulatory authorities regarding  products and technologies.
• Determining regulatory strategy and communicating  regulatory position within the company.
• Providing regulatory support to the users of company products worldwide with their product registrations, including responses to questions and generation of bespoke documentation to support the specific customer query, application or need.

QUALIFICATIONS AND PROFILE To be successful in your application to this exciting opportunity we’re looking to identify the following on your profile and past history:

• University Life Sciences Degree or equivalent level qualification. Masters or other postgraduate qualification in pharmaceuticals or regulatory affairs preferred.
• A minimum of 5 years regulatory affairs experience with pharmaceutical, preferably biotech/biological, products. For candidates with less 
role a Regulatory Affairs Officer instead, in which we would seek a minimum of 3 years regulatory affairs experience
• Comprehensive knowledge of biological and biotechnological (biotech) process and product development, GMP requirements and global registration procedures especially in the EU and US
• Experience in co-ordination and compilation of biotech product information for regulatory dossiers including master files, clinical trial applications, product license applications and medical device registrations.
• Competencies relevant for the role include: Ability to work in a proactive and autonomous manner, caring for standards to meet the needs of the business and to encourage and support high standards from others, managing complexity, resilient with the ability to proactively manage changing and evolving priorities and pragmatic

BENEFITS • 25 days annual leave, plus statutory bank holidays
• Attractive salary reflective of skills and experience, and a performance-based bonus scheme
• Defined contribution pension scheme
• Private healthcare scheme
• Optional exercise classes and other social activities
• Excellent access to public transport