Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Regulatory Affairs Manager

Eingestellt von Hays Resource Management - Astrazeneca

Projektbeschreibung

Contract length: 3 months

Location: Luton

Remuneration: Competitive

The role:

The Regulatory Affairs Manager will be responsible for:

- Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling
- Develop professional working relationships with assessors and administrative staff within the regulatory agencies
- Prepare high quality regulatory applications and regulatory responses for UK/Ireland/Malta Defend existing labelling and provide regulatory input into patent defence strategies
- Ensure timely submission of all licence variations and renewals and compliance with UK/Ireland/Malta licences
- Ensure clinical trial applications are filed to target, and amended to remain in compliance
- Assure appropriate standards and policies for all technical aspects of the company's activities in Regulatory Affairs
- Provide regulatory input/solutions to stock issues
- Liaise with Operations to manage pack changes and ensure labelling compliance
- Deliver the brand/commercial objectives, including representing Regulatory Affairs on Brand Lifecycle/Campaign Development/Customer shaping teams as appropriate
- Ensure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence
- Take a lead role in project management and delivery
- Understand and promote UK/Irish business needs into European strategies on drug development and regulatory filings/issues
- Ensure appropriate cross functional input into the delivery of optimal licence strategies
- Keep up-to-date with developments in the Regulatory Environment and share this knowledge across the department and beyond, in the business interest
- Ensure departmental processes and organisation are continuously reviewed for creativity, efficiency and productivity (including leading one-off major projects)
- Actively contribute to cross-functional team working within the Medical & Regulatory Directorate and other areas of the business
- Responsible for planning and executing workload for the defined product responsibilities and agreeing plan with Regulatory Team Manager

Qualification

- Life Sciences Degree or equivalent
- Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
- Experience of working with submissions in UK and Europe

Hays Talent Solutions is a trading division of Hays Specialist Recruitment Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be found on our website.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Hays Resource Management - Astrazeneca