Regulatory Affairs Professional for Respiratory and Immunology

2 weeks ago

London, Greater London, United Kingdom Lifelancer Full time
Seize Opportunities in Regulatory Affairs at Lifelancer

We are seeking a skilled Regulatory Affairs Professional to join our team in the Respiratory and Immunology department. As a key member of our organization, you will play a pivotal role in identifying regulatory strategies to support commercial and business objectives.

This exciting opportunity offers the chance to plan and execute workload for defined product responsibilities, manage the regulatory process, and negotiate with regulatory agencies to provide rapid approvals with competitive labelling.

About the Role
  • Job Title: Regulatory Affairs Manager
  • Location: London, England, United Kingdom
  • Job Type: Full-time

You will be responsible for:

  1. Identifying regulatory strategies to support commercial and business objectives and company efficiencies.
  2. Planning and executing workload for the defined product responsibilities and agreeing on plans with the Regulatory Affairs Lead.
  3. Proactively managing the regulatory process and effectively negotiating with regulatory agencies to provide rapid regulatory approvals with competitive labelling.
  4. Preparing high-quality regulatory applications and regulatory responses for the UK (including inputting into summary documents and responses for European applications).
  5. Providing regulatory input to commercial, medical affairs, market access, medical information, patient safety, and supply chain functions.
  6. Ensuring timely submission and approval of licence applications and maintenance activities and compliance with UK regulatory requirements.
  7. Assuring appropriate standards and policies for all technical aspects of the company's activities in Regulatory Affairs are adhered to.
  8. Providing regulatory input/solutions to supply and stock issues.
  9. Liaising with Operations to manage pack changes and ensure labelling compliance.
  10. Ensuring appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the license.
  11. Providing strategic regulatory input relating to AZ promoted and cornerstone brands, including competitor intelligence.
  12. Project managing and delivering projects of commercial strategic value.
  13. Understanding and promoting UK business needs into European strategies on drug development and regulatory filings/issues.
  14. Ensuring appropriate cross-functional input into the delivery of optimal licence strategies.
  15. Keeping up-to-date with developments in the Regulatory environment and sharing this knowledge across the department and beyond, in the business interest.
  16. Ensuring optimal departmental processes through continuous review.
  17. Actively contributing to the development, coaching, and training of the department, including new starters.
  18. Proactively managing the regulatory process for clinical trials for the UK.

As a Regulatory Affairs Professional, you will have the opportunity to make a significant impact on the success of our organization. If you are a motivated and experienced individual looking for a challenging role, we encourage you to apply.

What We Offer

We offer a competitive salary of approximately £60,000 - £80,000 per annum, depending on experience, as well as a range of benefits including a bonus scheme, health insurance, and retirement plan.

In addition, you will have the opportunity to work with a talented team of professionals, develop your skills and expertise, and contribute to the success of our organization.

Requirements
  • Degree: Life Sciences Degree or appropriate professional qualifications.
  • Experience: Significant experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company.
  • Skills: Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role.

Please note that we are an equal opportunities employer and welcome applications from all qualified candidates.

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