Are you highly motivated with the ability to understand and interpret complex regulatory legislation for multiple countries? Are you a regulatory professional with a degree (or equivalent) in life sciences?
Then look no further A fantastic opportunity has arisen for a Regulatory Affairs Executive to join our Regulatory Affairs department.
A day in the life of our Regulatory Affairs Executive
As a Regulatory Affairs Executive at Wockhardt, you will be a key member of the team, providing advice on the regulatory requirements for assigned projects, preparing and submitting variations, Article 61(3) applications, renewals and simple marketing authorisation applications in the UK, Ireland and other overseas territories and monitoring all of the above through to grant.
What we're looking for:
You will need an appreciation of all aspects of the workings of the pharmaceutical industry, an ability to present the Company's interests in a professional and authoritative manner and experience with information technology relating to regulatory affairs. You will have the ability to organise your own workload with a minimum of supervision, and have an exceptional eye for detail. We will also need you to have a degree or equivalent in life sciences, experience in regulatory affairs and ideally you will be a member of TOPRA (Organisation for Professional in Regulatory Affairs). Over-the-counter (OTC) product experience would be beneficial but not essential.
Job Content
* Determine and communicate submission requirements and assess the acceptability of documentation for submission.
* Preparing and collating documentation for marketing authorisation applications, renewals, eCTD baselines and variations. Monitoring 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 external/internal regulatory information requests.
* Commissioning artwork from the artwork team, reviewing artwork for suitability for submission, compliance for the marketing authorisation and company style conformance.
* Coordinate and prepare submission packages for regulatory agencies. 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.
* Assist in the development of variation submission strategies. Determine and communicate submission requirements and assess the acceptability of documentation for submission.
* Negotiating with regulatory authorities to achieve most favourable conditions for assigned applications.
* Liaising and negotiating with third party companies, such as contract manufacturers.
* Drafting of Summary of Product Characteristics and Patient Information Leaflets.
* Monitoring legislation and professional publications to maintain awareness of current regulatory practice.
* Operating and proposing administrative procedures within the Regulatory Affairs Department.
* Maintenance of regulatory database.
* Electronic publishing of regulatory submissions using dedicated software.
* Comply with departmental and company SOPs and proposing changes in their development and review, where appropriate.
* Represent regulatory affairs at internal meetings as directed by the Regulatory Affairs Manager.
* Operational use of and input to the Pharmaceutical Quality System will be achieved by maintaining the integrity of the Pharmaceutical Quality Systems, by engaging with and utilising the system in accordance with defined procedures and policies. The job holder will through supervisory guidance; contribute to improving the effectiveness of the Pharmaceutical Quality Systems by collection of metric data and other essential associated information which measures the system performance. In addition, they will actively contribute to and participate in continuous improvements to products, processes and the Pharmaceutical Quality System with the aim of minimising patient, customer and business risks.
Wockhardt has a range of benefits on offer for all employees including:
* Pension scheme – 7% matched contribution
* Rewards platform – discounts on shopping, restaurants, holidays and more
* Generous holiday allowance
* Salary sacrifice schemes
* Sports and Social club
* Subsidised canteen
* Free parking
You will be working from our Wrexham based site which is home to our MHRA approved sterile injectable manufacturing facility.
Job Types: Full-time, Permanent
Pay: Up to £50,000.00 per year
Benefits:
* Canteen
* Company pension
* Flexitime
* Free parking
* Work from home
Work authorisation:
* United Kingdom (required)
Work Location: In person