Head of Regulatory - Biologics work - 1 day in the office 4 days at home sound good?

Head of Regulatory Affairs

Salary -Negotiable

Location - Nottinghamshire / HYBRID ( 1 day a week in the office )

We are seeking a pragmatic and experienced regulatory professional to join us as Head of Regulatory Affairs to take responsibility for regulatory documentation, regulatory strategy and customer support pertaining to regulatory issues 

This role will appeal to you if you can take the lead on regulatory activities in relation to its  products and technologies. You’ll be exceptionally organized and have comprehensive knowledge of biological and biotechnological processes and product development, GMP requirements and global registration procedures (especially in the EU and US).

We are keen to speak with candidates who can demonstrate extensive experience in co-ordination and compilation of biotech product information for regulatory dossiers and those with excellent awareness of current requirements for biotech component products for use in the manufacture of other pharmaceuticals and medical devices.

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.

The role will be based in our newly renovated and modern offices  with flexibility for some hybrid working. The position is full-time and will entail a certain amount of overseas travel.

KEY RESPONSIBILITIES

• Oversee the submission and maintenance of regulatory filings.
• Apply knowledge of regulatory requirements to the review of scientific/process documentation and supporting country-specific documents intended for submission to regulatory authorities.
• Develop and implement  regulatory strategy for new products and life cycle management of registered products.
• Assess the impact of new regulations and guidance documents for making process improvements within the company.
• Respond to questions from regulatory reviewers from global agencies on  products and technologies.
• Provide regulatory support for  customers in a variety of therapeutic applications, including representing the company at customers’ meetings with the regulatory agencies.
• Develop and review staff performance, such as mentoring and recruiting staff.
• Manage department budget

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:

• Life Sciences, Chemistry, Pharmaceutical or Biotechnology university degree.
• A minimum of 7-10 years of regulatory affairs experience with pharmaceuticals, preferably biotech/biological products or advanced therapy medicinal products (ATMPs).
• Comprehensive knowledge of biological and biotechnological processes and product development, GMP requirements and global registration procedures, especially in the EU and US.
• Extensive experience in co-ordination and compilation of biotech product information for regulatory dossiers, including master files, clinical trial applications, product licence applications and medical device registrations
• Excellent awareness of current requirements for biotech component products for use in the manufacture of other pharmaceuticals and medical devices.
• Experience in working with state-of-the-art regulatory dossiers in compliance with eCTD structure, format and content with associated use of required software, e.g. Extedo, DocuBridge
• Broad experience in direct liaison with regulatory authorities (face-to-face meetings and online/telephone conferences), including agency personnel from FDA, EMA, European Commission, MHRA and Health Canada
• Good connections with relevant pharmaceutical trade organisations, e.g. International Pharmaceutical Excipients Council Europe (IPEC Europe), and Parenteral Drug Association (PDA).
• Demonstrated people management experience would be preferred

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