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Regulatory Affairs – Associate Director – Clinical Stage Biotech

Employer
Planet Pharma Staffing Limited
Location
Homebased in United Kingdom, France, Belgium, Germany or Netherlands
Salary
Highly Competitive
Start date
25 Nov 2021
Closing date
25 Dec 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

We have an exciting opportunity available as the Associate Director of Regulatory Affairs at a dynamic clinical-stage biotechnology company with a broad clinical pipeline of antibody therapeutics. This is a key hire within the global matrix team comprised of a diverse range of cross functional skill sets where cohesive work is the focus and titles get left at the door. This is the perfect position for someone looking to take ownership of the project and develop global strategies from the ground up. Starting in early phase but progressively working in both early and late phase. The position will work closely with the Head of Regulatory Affairs for the US, EMEA and Japan but will be responsible for designing their own Global strategy.

Responsibilities

  • Preparation and/or reviewing of documents for completeness and accuracy; interaction with project team members to assure completeness and timing with regulatory process.
  • Preparation of inventory documents based on checklists prepared by regulatory personnel and /or CRO.
  • Preparation and/or reviewing of regulatory documents for Agencies in US, EU or ROW with R&D team members.
  • Conduction of initial review of regulatory agency publications.
  • Preparation and distribution of regulatory agency contact reports and meeting minutes.
  • Arrangement of regulatory meeting components within project teams or regulatory agencies.
  • Increasing knowledge of regulations and guidelines within the regulatory team.
  • Oversight and conducting of QC checks of materials prepared by the project team or external.
  • Assisting with project management, and other tasks as required by regulatory team members.
  • Attendance of regular project team meetings.
  • Development of regulatory strategy and preparation and conductance of Agency meetings Taking s care of the development of risk assessment and risk mitigation
  • Filing of all matters related to nonclinical reports and clinical trials for regulatory activities from Phase 1 to 3 according to CTD.
  • Support in preparation of activities prior to BLA/MAA.
  • Provision of responses to regulatory agencies with support of the project team. Ensuring that the document content is aligned with regulatory expectations in US, Japan and EU.

Requirements

  • 5-10 years experience in Regulatory Affairs within the Pharmaceutical/Biotechnology sector
  • Global experience would be ideal however experience covering EU and US will be sufficient
  • Leadership experience. This can include experience in a matrix environment, managing a cross functional team
  • Experience filing IND, BLA/NDA and marketing authorisation applications.

Following your application Simon Trebilcock, a specialist Pharmaceutical Recruiter with over 7 years’ experience recruiting in the field will discuss the opportunity with you in detail. He will be more than happy to answer any questions relating to the pharmaceutical industry and the potential for your career growth. The conversation can also progress further to discussing other opportunities which are also available right now or will be imminently becoming available.

This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click ‘apply’ or contact Simon Trebilcock for any further information

Email -  strebilcock@planet-pharma.co.uk

Telephone - +44 (0)203 928 6632.

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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