Regulatory Affairs Specialist

  • Salary: £20-£34 phr
  • REF Number: 00046574
  • Consultant: Lucy Stendall
  • Contact: 01246 457725
  • Date Published: 17.09.2019
  • Closed Date: 03.10.2019
  • Sector: Non-Specific
  • Location: Home Counties
  • Discipline: Regulatory Affairs

CK Group is recruiting for a Regulatory Affairs Specialist to join a company in the Pharmaceutical industry at their site based in Hoddesdon on a contract basis for 12 months.

The Company: Our client is committed to improving health and wellbeing around the world and are a global healthcare leader. Today, they are at the forefront of inventing tools for the fight against some of the world's most urgent global health challenges. This includes more than 30 different cancers, hepatitis C, Alzheimer's disease, Ebola, antibiotic-resistant "superbugs", cardio-metabolic diseases, and many others. Their products cover a broad range of areas, including cardiovascular disease and immunology, infectious diseases, and women's health.

The Location: This role is located just off the A10 and on the outskirts of Hoddesdon itself. Hoddesdon is a town in the Broxbourne borough of the English county of Hertfordshire, situated in the Lea Valley. It is located 3 miles West of Harlow 4 miles southeast of Hertford, 5 miles north of Waltham Cross and 11 miles southwest of Bishop's Stortford, offering many nearby attractions, restaurants, pubs and clubs. The site itself can be reached via public transport with ease. There are three nearby train stations, the closest being Rye House Station.

The Role:

  • Responsible for providing HRM-related support for all Country Regulatory Affairs (CRA) staff in their region.
  • Responsible for providing guidance and direction to CRA to ensure the Regulatory Information entered into the HRM system is accurate, complete and timely.
  • Carry out direct data entry into the system in support of normal regional business activities, regional data clean up, and will lead correction and remediation activities.

Key Responsibilities:

  • Assist in the identification and resolution of data-entry- related errors within the specified region.
  • Develop standard responses for common queries which can then be used as “mini refreshers” for the HRM Community of Practice meetings.
  • Assist in enforcing and supporting regional procedures to ensure HRM data entry and usage compliance.
  • Support, and at times lead, efforts surrounding HRM regional specific projects and maintain appropriate metrics.• Assist in the implementation of HRM data quality strategies in the region and support users in the execution of the strategy at the country level.
  • Stand up and support regional communities of practices with the region.
  • Assist in, and where appropriate take the lead in, the evaluation of metrics from the HRM data monitoring plan to determine where process changes, communication, and training/retraining may be needed to improve overall data quality.

Your Background:

  • Bachelor's degree with 6 years of industry experience, at least 5 of those in a regulatory/compliance industry with emphasis on system support OR Master's Degree with a minimum of 4 years of industry experience in a regulatory/compliance industry with emphasis on system support required
  • Knowledge of EU regulatory procedures e.g. MRP/DCP, CP
  • Proven experience analysing information in support of data entry activities
  • Demonstrated problem-solving skills
  • Broad organizational awareness and knowledge of touch points/interdependencies
  • Ability to lead and influence others
  • Fluent in English

For more information or to apply for this position, please contact Lucy on 01246 457725 or email pharmacontracts@ckagroup.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46574 in all correspondence.

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