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Regulatory Affairs Associate Director / Director

Employer
Hobson Prior
Location
England, Essex, Harlow
Salary
£95000.00 - £100000 per annum
Start date
14 Oct 2019
Closing date
11 Nov 2019

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

Hobson Prior are looking for a Regulatory Affairs Associate Director / Director to join a leading pharmaceutical consultancy who are committed to providing high quality strategic and operational services to the pharmaceutical and biotechnology industry.

Job Responsibilities:

  • Responsible to manage the EMA procedures, this will include orphan applications, PIPs and MAAs.
  • Support the company in providing regulatory knowledge to business development colleagues during bid defence.
  • Offer expert EU regulatory strategy.
  • Represent as the first point of contact for agency interaction.
  • To be a client lead.
  • Provide leadership in scientific advice meetings at national agencies and EMA.
  • Project management/lead responsibilities.
  • Client facing with strong communication skills, willing to travel.
  • Support the senior management team by providing leadership support to a team of internal consultants and their clients.

Key Skills:

  • Innovative and pragmatic problem solver.
  • Attention to detail.
  • Confident speaker about regulatory challenges in the clinical development of biological and next generation technologies and approaches to finding solutions.
  • Strong communicator with the ability to influence and lead team members.
  • Completer-finisher able to provide decisive leadership in a project team setting.
  • Ability to work under pressure and achieve timely submission and regulatory approvals.

Requirements:

  • Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines.
  • A minimum of 5+ years broad & deep European regulatory affairs experience with demonstrable experience in liaising and negotiating with regulatory authorities and point of contact with EMA.
  • Demonstrable experience in centralised MAAs, orphan applications and PIPs.
  • Strong understanding of the regulatory environment including guidelines.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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