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Regulatory Specialist - NPI job in King's Lynn at Aesica Pharmaceuticals Limited

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Regulatory Specialist - NPI at Aesica Pharmaceuticals Limited

Regulatory Specialist - NPI

Aesica Pharmaceuticals Limited King's Lynn, Norfolk Full Time

Shift Details:

Days 37.5hours

Salary: Negotiable DOE + Benefits 

Candidate Information Pack including benefits:

Have you got Regulatory experience in a Medical Device/Pharmaceutical environment? If so, we have an opportunity to join our team. 

As a key member of the Regulatory team you will provide specialist advice and information throughout the company to understand, plan and support the design, development, and commercialisation of products with a focus on New Product Introduction (NPI) programmes. You will work closely with internal stakeholders, customers and suppliers/other companies to understand, plan and execute the design and development stages and develop regulatory strategies for NPI ensuring relevant standards and guidance’s are identified and incorporated as required ensuring compliance at all times for regulatory submissions and licences.

Some of the key responsibilities will include but not limited to the following:

  • Identify, define, and deliver of Regulatory deliverables for NPI programmes and marketed products as required to ensure product quality and compliance, within agreed cost and timelines.
  • Develop and maintain up to date relevant legislative, compliance and regulatory knowledge applicable to the company. Ensure that Pharmaceutical, Medical Device and Drug-Device Combination Product Regulatory Affairs policies, procedures and processes are revised as required, to ensure compliance and followed at all times.
  • Keep up to date with the applicable regulatory changes, proactively conduct impact assessments and effectively communicate outcomes.
  • Represent the Company on regulatory issues at customer audits / visits and regulatory authority inspections / audits. Following up on any actions to ensure the company is compliant.
  • Assist with the management and co-ordination of external audits and inspections. 
  • Provide direction, advice, training and guidance to employees regarding compliance and regulatory issues, including the review and implementation of QMS transactions (e.g. change controls).
  • Proactively pursue continuous improvement opportunities within the Regulatory processes.
  • Formulate, develop and maintain all applicable Regulatory submissions (e.g. DMFs) and licences (e.g. MHRA) to ensure compliance with Regulatory requirements to enable product launch and change implementation per business plan.
  • Maintain regulatory licences, site registrations and listings to ensure they are current.
  • Manage and maintain records of all required Regulatory compliance statements and certificates within the agreed timeframe to ensure that customer requests are met.
  • So, if you have the experience and skills, we’re looking for in this role apply today and help us continue to deliver high quality products for our customers and patients. 

    To be successful in this role we’re looking for you to have the following skills, experience and knowledge:

  • Minimum of 3 to 5 years’ experience working in Regulatory ideally in Medical Device, IVD, combination product or Pharmaceutical industry ideally with NPI products. 
  • Previous experience of interpreting legislative requirements at various stages of a product lifecycle with the ability to translate this information to non-regulatory colleagues.
  • Good working knowledge of ISO 13485, 21 CRF Part 820, ISO 14971, ISO 10993, GMP, European Medical Device Regulation, QSIT.
  • Ability to manage changing priorities adapting to multiple projects at the same time.
  • To view the full job description:

    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 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 

    Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) in the pharmaceutical industry employing almost 9,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, pharmaceutical product development and development and manufacturing of medical devices. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. 

    Bespak Europe Ltd is part of the Recipharm group. We are 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.

     

    Recommended Skills

    • Medicines And Healthcare Products Regulatory Agency (Mhra) Guides
    • Iso 13485
    • Iso 14971
    • Good Manufacturing Practices
    • Product Quality Assurance
    • New Product Development
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    Job ID: 024efb828455