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Regulatory Affairs Officer

Owen Daniels Consultancy
Job LocationNottingham
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time Work from home

Job Description

Regulatory Affairs OfficerPermanent Position Competitive Salary9AM5PM, Monday-Friday (Flexible hours)Hybrid working NottinghamOur ever-growing client is a very well-known producer of biopharmaceutical products and technologies. They are looking for an experienced Regulatory Affairs Officer to join the team, and the main purpose of the role will be to ensure products are manufacturedand distributed in compliance with appropriate legislation. The ideal candidate will hold a degree within a related industry and will have strong experience carrying out a similar regulatory affairs position, within a pharmaceutical-based industry (preferablybiotech/biological, products).Regulatory Affairs Officer Job Description

  • Act as a link between the company and regulatory authorities, ensuring products are manufactured and distributed in compliance with appropriate legislation. The profession offers opportunities for travel and international employment
  • Conducting interactions with regulatory authorities regarding products and technologies
  • Maintaining awareness of the wider regulatory landscape, taking responsibility for Regulatory Intelligence within the department and disseminating this information as required
  • Reviewing change controls to provide regulatory assessment of changes where required and implementing changes with support of other department members
  • Maintaining and creating databases and work schedules as required within the department
  • Providing input and support to other groups including cross-functional teams as required
Regulatory Affairs Officer Essential Skills/Experience/Qualifications
  • University Life Sciences Degree or equivalent level qualification
  • Strong regulatory affairs experience with pharmaceutical, preferably biotech/biological, products
  • Knowledge of biological and biotechnological (biotech) process and product development, GMP requirements and global registration procedures especially in the EU and US
  • Experience in co-ordination and compilation of product information for regulatory dossiers including master files, clinical trial applications, product licence applications and medical device registrations
  • Excellent organisational, planning and prioritisation skills
  • High attention to detail and strong communication skills
Company Benefits
  • Pension: Company pays 7.5% of salary pension contributions
  • Private Healthcare: Company pays full premiums for either Single, Couple of Family membership
  • Bonus: Annual company bonus scheme.
  • Annual Leave: 25 days plus all bank holidays
  • Exercise classes: Free Yoga and Pilates classes

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