Analyst – Quality Control
Elvis Eckardt Recruitment
Regulatory Affairs Officer
Sanofi
full-time
Posted on:
Location Type: Office
Location: Reading • 🇬🇧 United Kingdom
Visit company websiteJob Level
Junior
About the role
- Co-ordinates, prepares, submits and follows up registration applications to the UK and/or Irish regulatory authorities to obtain and maintain marketing authorisations
- Prepares and submits responses to enquiries and deficiencies noted by regulatory authorities
- Prepares and reviews labelling, package leaflets and summaries of product characteristics to ensure compliance and secure regulatory approval
- Supports the launch of new products and life cycle management of the existing portfolio
- Ensures all data supplied to regulatory authorities are high quality in content and presentation and meet agreed deadlines
- Works proactively with Global Business Units and other Global functions to meet project needs compliantly within agreed timelines
- Assists management in providing strategic input into development of registration strategies and operating planning processes for commercialisation of products
- Contributes to the effective running of departmental and cross functional project teams and leads projects when required
- Provides regulatory input, with support, to commercial strategic and operating planning process
Requirements
- At least 1 year experience working in Regulatory Affairs, preferably up to 2 years
- Understanding of lifecycle maintenance for pharmaceutical products, particularly variations
- Proven project management skills
- Biologicals and/or Vaccines experience desirable
- Life sciences or chemistry degree or equivalent professional qualification or proven relevant experience within the regulatory environment
- Proven familiarity with the pharmaceutical research and development process with ability to integrate scientific information from a variety of disciplines
- Ability to work across a variety of therapeutic areas and represent Regulatory at brand meetings (with support)
- Awareness of EU regulatory procedures for marketing authorisations and submission to regulatory authorities
- Awareness of lifecycle maintenance for pharmaceutical products, including variations and renewals
- Awareness of ABPI and IPHA code, promotional and non-promotional materials and PI
- Awareness of product quality and Good Manufacturing Practice (GMP) requirements
- Understanding of CMC changes and ability to identify changes to registered details
- Understanding of the Common Technical Document (CTD) and pharmaceutical dossier structure
- Administratively well organised with attention to detail and strong written and oral communication skills
- Able to communicate effectively and efficiently with other functional departments in the business
Benefits
- Thoughtful, well-crafted rewards package that recognizes your contribution
- Wide range of health and wellbeing benefits including high-quality healthcare
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
- Opportunities for career growth, promotion or lateral moves
- Supportive, future-focused team and inclusive workplace
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Regulatory AffairsProject ManagementLifecycle MaintenancePharmaceutical Research and DevelopmentCommon Technical Document (CTD)Good Manufacturing Practice (GMP)BiologicalsVaccinesCMC ChangesProduct Quality
Soft skills
Attention to DetailStrong Written CommunicationStrong Oral CommunicationOrganizational SkillsProactive CollaborationStrategic InputCross-Functional Team LeadershipEffective CommunicationAbility to Work Across Therapeutic AreasAdministrative Organization
Certifications
Life Sciences DegreeChemistry DegreeEquivalent Professional Qualification
