Head of Regulatory & Compliance

Bespak Europe Limited
King's Lynn, UK
21 Apr 2019
16 Apr 2019
Contract Type
Level of qualification
Job title:
Head of Regulatory & Compliance

King's Lynn, Norfolk. PE30 2JJ Do you want to utilise your knowledge and experience of EU & USA Regulatory Filing processes for Medicines and Medical Devices through product life-cycle including injectable, nasal and oral pMDI combination product to lead our regulatory affairs function? As Head of Regulatory Compliance you will provide strategic regulatory expertise and oversight to support the design, development and commercialisation of products and will lead the Regulatory Affairs function in the company. In this role you will:
• Credibly represent the regulatory function in senior level interactions at internal governance, technical review committees or steering groups.
• Provide effective strategic technical guidance to cross-functional submission teams.
• Apply effective judgement and decision-making in complex business critical situations, escalating risk impact to the Quality and Regulatory Director as needed.
• Lead, motivate, coach and develop direct reports to perform to a consistent high standard.
• Interpret new and changing regulations to ensure that Bespak is not under or over regulated.
• Maintain effective working relationships with Regulatory bodies, e.g. FDA, MHRA & Health Canada and Notified Bodies as well as our clients
• Set the Quality and Regulatory framework for our new project teams We are committed to creating a diverse and inclusive workplace where all employees feel that they can be their real and authentic selves whilst being treated with dignity and respect. We are an equal opportunity employer who will review your application based solely on your skills, experience & potential. What we offer you We want to provide an environment where our colleagues play an active part in the growth of our business. A challenging but supportive environment where talented people can really grow and take advantage of a wide range of diverse opportunities that we offer. We regularly benchmark ourselves against our industry and we are confident that we offer a competitive salary and benefits package to all our colleagues including 28 days holiday plus statutory holidays, 8% employer contribution to pension scheme, private medical insurance, group life assurance, employee share schemes and an active well-being programme. Great locations as well as a positive, people-focused culture with charity and social activities a part of everyday life. It all contributes to creating a working environment which is friendly, supportive and nurturing. Millions of patients all over the world rely on what we do Bespak is a global market leader in the development and manufacture of drug delivery devices. We provide pharmaceutical companies around the world with inhaler and auto-injector technologies and development and manufacturing services. Our culture is driven by five core values. Integrity > Respect > Team Work > Results Driven > Customer Focus Integrity drives mutual Respect. Integrity and Respect are the basis for Team Work. Integrity, Respect and Team Work promote a Results Driven and Customer Focused culture. ........................... Making your application To apply for this role please click "Apply Now" and upload a CV and a separate cover letter. Without both of these your application will be incomplete. We're flexible. We understand that there is a life outside of work so we aim to support you in attaining a happy work/life balance. To cater for employees' individual circumstances, where possible, we agree flexible working arrangements. We're inclusive. We are proud to be a Disability Confident employer. We will support you throughout the recruitment process with any adjustments you require. Please contact the Recruitment Team if you require support. Don't delay Please submit your application as soon as possible as we will be reviewing applications for this role as they are received and reserve the right to close this advert without notice. By applying to this role you are giving consent to Consort Medical to process your personal data for employment/ recruitment purposes only. All the personal and sensitive data processed to Consort Medical is protected under GDPR regulations. To find out more about our privacy policy please visit our website or contact the local HR team.