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Senior Manager - Regulatory Affairs (Labelling)

Employer
Xplore Pharma
Location
London
Salary
£40 - £55 per hour
Start date
26 Oct 2022
Closing date
25 Nov 2022

View more

Discipline
Regulatory Affairs, Labelling, Regulatory Writing
Hours
Full Time
Contract Type
Contract
Experience Level
Management
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Job Details

Xplore Life Sciences are recruiting for a Senior Regulatory Affairs Manager (Labelling) for work with a leading American Professional Services Company within the Clinical Domain. 

Location will be fully remote with offices also located in Paddington, London. 

You must have valid right to work in the UK

Responsibilities:
  • Monitor and develop continuous improvement proposals on the processes
  • Maintain a staff of adequately skilled resources to meet deliverables
  • Communicate issues and resolve them in an appropriate time frame
  • Ensure adherence to agreed-to work practices
  • Meet established submission timelines and quality standard.
  • Participate, as needed, on global teams to complete assignments and tasks within a specific task force/project associated with labelling
  • Ensure collection of metrics
  • Improve speed to minimize the cost
  • Identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions

Minimum qualifications
  • Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives
  • Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts
  • Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in speaking publicly to senior management when required
  • Must be able to construct a Company Response (MAH response) for health authority questions
  • Masters in Life Sciences
  • Understanding of key regulatory and Labeling principles and SOPs
  • Should be open to work in any shift as per the business requirement

Preferred Qualifications
  • 6-9 years’ experience in Regulatory affairs
  • Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields.
  • Marketing authorization experience.
  • Proven Project Management experience

Company

Xplore Life Science is a Life Science and Pharmaceutical Recruitment Consultancy providing an expert service, we are a challenger life science search firm. We place specialist talent within pharma, medical device, medical technology and consultancy businesses in the UK, Benelux, Switzerland (SECO License), Germany and the USA. Delivering on a contract, interim, permanent and retained search basis through a client-centric, transparent and lean recruitment process. Xplore are fully invested in our clients and candidates, focusing on delivering results for all parties, we are Dedicated to Life Science talent.

Find Us
Website
Telephone
+44 (0)203 865 5705
Location
154-158 Shoreditch High Street
London
England
E1 6HU
United Kingdom
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