Naukrijobs UK
Register
London Jobs
Manchester Jobs
Liverpool Jobs
Nottingham Jobs
Birmingham Jobs
Cambridge Jobs
Glasgow Jobs
Bristol Jobs
Wales Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Associate Director Regulatory Affairs

Haybury Limited
Job LocationLondon
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

My client is one of the largest globally operating pharmaceutical companies specialising in therapeutics within oncology, neuroscience, rare diseases, and gastroenterology. To assist in their aspirations to be a dynamic R&D organization that thinks, acts and interacts with the external world like no other, we are looking for an Associate Director of Regulatory Affairs to join the company on a 6-month contract based in their London offices (remote working currently).You will be:

  • Leading the regulatory working team for the region and represent at project team level ensuring regional regulatory lifecycle management strategy and submission planning are written and executed according to plan
  • Partners with the regional/LOC RA and market access colleagues to understand market access and reimbursement requirements and to ensure consolidated inputs into regional product development plans
  • Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within the region (s) of responsibility (E.g. EMA submissions for Europe).
  • Understand the importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed
  • Identifying relevant regional regulatory requirements and providing regulatory guidance, and expertise to the internal team on the assigned project(s) of responsibility
  • Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve Takeda strategic goals and objectives.
  • Identifying regulatory requirements and trends across the area(s) of responsibility, and providing regulatory guidance, and expertise to the global development team and/or higher governance bodies in these areas, as requested.
  • Identifying and proposing solutions to the management of resource gaps for areas of responsibility
    • You must have:
  • Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
  • Experience with interactions with EMA, oncology drug development and EU orphan applications
  • Preferred experience in managing major regulatory filing(s); and a significant contributor to regulatory and/or development strategies
  • Solid working knowledge of regulations and guidelines governing drugs and biologics in all phases of development, including post-marketing, in the EU
  • BSc degree or equivalent in science BSc degree or equivalent in science
  • Strong leader who is an effective manager with the ability to mentor and develop skills of team members
  • Experience in managing relationships with CROs and contractors
    • In return you will receive:
  • A role in a leading pharmaceutical organisation
  • The ability to work in an energetic, motivated team
  • A competitive salary
  • Identification and the reward for outstanding accomplishments
  • The ability to develop within a supportive and development orientated organisation
    • If you have the skills and experience for this opportunity and the ambition to take on this position, please call Alouette for further details or email your CV today.Alouette is a Search Consultant at Haybury Search covering Europe, UK, North America and Asia.

    APPLY NOW

    Associate Director Regulatory Affairs Related Jobs

    © 2019 Naukrijobs All Rights Reserved