Senior Regulatory Specialists

Location Wrexham
Discipline: Pharmaceutical
Job type: Permanent
Salary: £Negotiable
Contact name: Simon Fowler

Contact email:
Job ref: BBBH2872_1633708713
Published: 11 days ago

Senior Regulatory Executives £45-£50k

Up to £50k with Line Management Experience in Regulatory Affairs

Up to £45k with 3 Years plus experience in Pharmaceutical Regulatory Affairs

Wrexham; Commutable from Cheshire, North Wales & Shropshire - The company also offer home working & flexi-time to accommodate longer commutes.

Ll13 9UF

Wockhardt UK is a diverse pharmaceutical business, ranking amongst the top 10 generic pharmaceutical companies in the UK. We are a major supplier of pharmaceuticals to the Retail Pharmacy, Hospital and Grocery sectors. With a thriving Export Division also in place, this is an exciting time for Wockhardt UK.

Supported by our parent company's global strength, research base and impressive product pipeline, we are set for growth.

As the Senior Regulatory Affairs Executive you will;

  • Become Senior Executive in a dynamic team of Regulatory professionals
  • Manage a broad range Regulatory processes for the extensive range of dosage forms registered by Wockhardt globally

A day in the life of a Senior Regulatory Affairs Executive

  • Marketing authorisation applications: manage, coordinate and prepare submission packages for assigned new products (generic, hybrid, well-established use). Monitor the content of the dossiers ensuring the content is consistent, understandable and the results clearly expressed and that open questions have been dealt with
  • Respond to questions raised by regulatory authorities by obtaining the relevant information from departments concerned
  • Negotiate with regulatory authorities to achieve most favourable conditions for marketing authorisations or variations
  • Propose and implement regulatory strategies for post-licensing variations to ensure compliance and maintain continuity of supply
  • Monitor legislation and professional publications to maintain awareness of current regulatory practice and provide information on regulatory requirements to other departments and/or business units
  • Review GMP documentation, including change controls, for regulatory compliance and evaluate the regulatory impact
  • Review artwork for compliance to the marketing authorisation and company style conformance prior to approval
  • Represent regulatory affairs at internal and external meetings, as required

What we're looking for

  • Degree or equivalent in life sciences
  • Good technical knowledge of European Regulatory Affairs, particularly in CMC
  • Post-approval submission experience: renewals and all types of variations
  • Experience of new product submissions in the UK would be beneficial
  • You will be self-motivated, have an exceptional eye for detail and excellent problem-solving and decision-making capabilities
  • You will have the ability to multi-task and to plan and prioritise your workload to meet expected deadlines
  • You will be able to communicate effectively with people at all levels within and external to the organisation and to present the Company's interests in a professional and authoritative manner

Please apply now to be considered for these roles immediately