Regulatory Affairs Manager

Employer
Hobson Prior
Location
England, Hertfordshire, Stevenage
Salary
£60000 - £65000 per annum
Closing date
17 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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Hobson Prior are looking for a Regulatory Affairs Manager to join a clinical-stage biotechnology company on a permanent basis in Stevenage. You will participate in the development and implementation of regulatory strategy for specific programmes.

Job Responsibilities:

  • Support the Global Regulatory Companion Diagnostics (CDx) Lead to implement a successful co-development strategy that bridges across the assigned gene therapies and companion diagnostics.
  • You will support global regulatory sub-team and product development teams in all aspects of regulatory affairs, both strategic and operational, and provide input into relevant sections of development plans for assigned programmes.
  • Ensuring preparation and submission of high-quality regulatory documents.
  • Represent as the contact point for internal and external clients, including CROs and regulatory authority interactions.
  • Accountable for the regulatory project management for assigned projects i.e. planning and tracking submission and approval timelines, regulatory commitments, etc.
  • Contribute to the growth of the Function, including supporting GxP compliance and inspections and regulatory systems.
  • Remain expert and up to date on global regulatory requirements including nonclinical and clinical aspects.
  • Keep up-to-date of relevant regulatory intelligence and ensuring this is communicated, appropriately, across the Company.
  • Assist with training of staff in regulatory matters as required.

Key Skills:

  • Strong influencing and interpersonal skills including strong oral and excellent written communication skills.
  • Highly computer literate.
  • Ability to work effectively and collaboratively in a matrix environment across different personalities/cultures and functions.

Requirements:

  • Relevant degree in a life science / science discipline.
  • A minimum of 6-8 years' experience in regulatory affairs across various companies preferably in biotechnology/biologicals and/or rare diseases in a centralized European setting where US experience would be a bonus.
  • Knowledge and understanding of EU and ICH guidelines and experience of working to GxP is essential.
  • Experience in the preparation of regulatory submissions during the lifecycle particularly INDs/CTAs, scientific advice briefing documents, PIPs and/or orphan designation applications or sections of the MAAs/NDAs and/or post-approval submissions.
  • Interactions with the EMA and European national regulatory authorities required (any experience with FDA interactions would be a bonus).

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.

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.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
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