Senior Regulatory Affairs Specialist
We’re hiring for a Regulatory Affairs Specialist to join our Regulatory Affairs team. In this role you will be responsible for
• Completing and maintaining all regulatory documents e.g. MHRA licenses, DMF etc.
• Working with regulatory authorities, customers, suppliers and laboratories to ensure all information is up to date and compliant.
• Representing the company during customer visits, audits and regulatory authority inspections.
To be successful in this role we’re looking for you to have the following skills, experience and knowledge
• Demonstrable experience in EU and USA regulatory filing processes for Medicines and Medical Devices.
• Knowledge of pharmaceutical and drug licensing processes and legislation.
Experience and knowledge of TOPRA, combination products, Chinese FDA and DMF
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.