Vice President of Regulatory Affairs - Biotech

2019-04-11 16:00:092019-05-09LinkField Life Sciences
Job TypePermanent
AreaNorth London, UK
SectorPharma / Biotech
Salary£ 0 ~ 0 Competitive
Job Ref0064I00000tNLuLQAW
Job Views558
Description

This is a new appointment for a Vice President of Regulatory Affairs working for an inspiring company who are at the forefront of developing life-changing Gene Therapies. With three Gene Therapy products and an exciting pipeline, we are seeking a seasoned professional with a passion for Gene Therapy and making a real difference to patients lives.


Choice of three Locations:

Hertfordshire, UK / Boston, US / New York, US (Flexibility for a combination of office and home-based working)


The appointed candidate will be accountable for all aspects of Regulatory Affairs in all territories in which the company operates. This includes clinical, CMC and Regulatory Operations. As the company grows the Vice President of Regulatory Affairs will be responsible for building an effective Regulatory Affairs function that continues to meet the needs of the company.


Responsibilities include:

·        For each product in development the creation, agreement and delivery of a global Regulatory strategy, that is consistent with business objectives.

·        Ensuring preparation of high-quality Regulatory documents including, but not limited to, IMPD/CTA/IND, briefing documents, orphan drug applications, paediatric investigational plans, MAA/BLA and other Regulatory filings

·        Proactively identifying risks to the Regulatory plans and developing ways to mitigate risks

·        Taking responsibility for training of staff in Regulatory matters as required 

·        Leading and managing Regulatory authority interactions

·        Provide strategic direction and operational Regulatory support to the project teams and other groups within company as required

·        Keep abreast of relevant Regulatory intelligence and ensuring this is communicated, appropriately, across the company.

·        Managing third party providers such as Regulatory service providers and medical writers to ensure business objectives are met

·        Remain up to date on global Regulatory requirements including clinical and CMC aspects.


Education and Previous Regulatory Experience Requirements:

·        Bachelor degree in Life Science - Master or PhD preferred

·        Significant experience in Regulatory Affairs including experience of European and US Regulatory environments from early development, through CTA/IND, to filing of MAA/BLA and maintenance of approvals.

·        Japanese Regulatory Affairs experience would be beneficial.

·        Experience of the development of GTMP (Gene Therapy Medicinal Products) and rare disease products with a strong working knowledge of the Regulatory requirements including knowledge of accelerated and conditional approval routes within FDA and EMA.

·        A proven ability to create and drive an effective clinical Regulatory strategy.

·        Experience of planning and leading meetings with the FDA, the EMA and European national Regulatory authorities


To book a confidential discussion regarding this appointment please email Natalie directly with your details to arrange a call Natalie@linkfieldgroup.com


Apply Later
Sign in
Register
Apply
Later
Register with
Natalie Hopkins
Recruitment Director
Browse Natalie's jobs
View Natalie's bio
Get in touch with Natalie
0207 183 5059
Similar Jobs
  • Global Regulatory Manager - Contract
    UK, London, Central London
    Pharma / Biotech
    £ 60 ~ 70 Hourly Rate

    We are currently partnering with a Global pharma company who are looking for a Global Regulatory Manager to work on a mixture of Emerging Markets and EU Post Marketing activities. The selected professional will be a confident leader who is comfortable working on a variety of products and projects. ...
  • Regulatory Affairs Manager – Medicines
    UK, London, North London
    Pharma / Biotech
    £ 0 ~ 0 Competitive

    Regulatory Affairs Manager – Medicines Location: Hertfordshire (option for 1 day home working)Salary: Competitive Annual Salary + 25 days holiday, Life Assurance, leave early on a Friday, Pension Scheme, Buy and Sell Annual leave, Non-Contractual Annual Bonus We are currently working with a growi...
  • Senior Regulatory Affairs Officer
    UK, Greater London
    Pharma / Biotech
    £ 40,000 ~ 45,000 Competitive

    This a new position in a growing Regulatory team with one of our key partners. The role:Obtaining new and maintaining existing Marketing AuthorisationsMaintaining regulatory activities related to one or more new drug applicationsMaintaining drug licences for designated products in a designated terri...
Email Me Jobs Like This
Subscribed to similar jobs notifications

To find out more about Linkfield Life Sciences Ltd, and how we can partner with you to support your Regulatory Affairs recruitment requirements, please contact us below:

WE’RE EASY TO FIND

Office 2b
Mercury House,
High Street,
Tattenhall, TN8 6EN

  • 0207 183 5059
  • info@linkfieldgroup.com
We use cookies to provide you with the best possible browsing experience on our website. You can find out more below.
Cookies are small text files that can be used by websites to make a user's experience more efficient. The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission. This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages.
+Necessary
Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. The website cannot function properly without these cookies.
ResolutionUsed to ensure the correct version of the site is displayed to your device.
essential
SessionUsed to track your user session on our website.
essential

More Details