Regulatory Affairs Associate Director
ProClinical is advertising a vacancy for a Regulatory Affairs Associate with a major biotechnology company. This organisation, which prides itself on its extensive pipeline and commercial portfolio in oncology and immunology, provides life-changing drugs that treat diseases which have unmet medical needs. The company is seeking applicants to join its office in Uxbridge.
- Contributing to the development of EU regulatory product strategy based on company strategic imperatives, product knowledge, global, and regional regulatory requirements, including assessment and inclusion of innovative regulatory pathways to achieve regulatory approvals meeting business needs.
- Working with Regulatory Franchise Team Leadership to ensure that EU regulatory product strategy and deliverables are developed in alignment with Global Regulatory Affairs (GRA) and the Global Project Team (GPT).
- Maintaining awareness of emerging issues that may impact regulatory product strategy and Company EU regional business.
- Proposing adjustments to strategy and implementation plans in response to new information or changes in the competitive landscape and consults with management.
- Maintaining knowledge of current EU regulatory guidance and procedures and reviewing new guidance for impact on regulatory product strategy and discusses with management.
- Working with Regulatory Franchise Team Leadership to ensure that product development programs and life-cycle plans are aligned with company strategic oversight, business model, Global, and EU regulatory requirements.
- May have global responsibility for specific projects which will require a knowledge of global regulatory requirements, development and ownership of the Regulatory Development Plan (RDP), responsibility for worldwide submission plans, and accountability for global regulatory documents such as clinical trial/marketing applications and for interactions with global Health Authorities.
- Responsible for or contributing to the execution of regulatory product strategy and for achieving timely regulatory approvals with competitive product labels and the maintenance of licences for products assigned.
- Working with other functions as necessary, developing and contributes to the preparation and content of high quality regulatory dossiers (e.g., scientific advice requests, orphan medicinal product designation applications, paediatric waiver requests, MAAs and variations), ensuring compliance with regulatory requirements.
- Contributing to the review of key documents before submission.
- Responsible for or participating in interactions with the European Medicinal Agency (EMA), and National Regulatory Health Authorities within the EU for product related discussions.
- Supporting or may be responsible for ensuring that Company fulfils Health Authority commitments.
- May represent RA at Governance Committees
- Ensuring that GRA, GPT, RA EMEA Labelling, Regulatory Operations, and Affiliate Regulatory are kept updated in a timely manner, on regulatory product plans, progress and operational issues
- Reviewing draft protocols, acting as Regulatory Franchise Team representative in clinical study teams, and liaising with the individuals with CTA or CRO oversight responsibility.
- Acting as Subject Matter Expert on designated studies in the event of the Health Authority Inspection.
- Responsible for the delivery of Content Plans to allow publishing and timely dossier submission.
- Responsible for tracking and communicating regulatory activities within RA and for ensuring that submission plans are captured accurately..
Skills and Requirements:
- Bachelor's degree in scientific discipline or equivalent required.
- Experience in EU Regulatory Affairs & recent experience of EU Centralised Procedure required.
- In-depth knowledge of current EU regulatory requirements essential.
- In-depth understanding of CTD modules; non-clinical, CMC, Clinical.
- Thorough understanding of core processes of drug discovery, development, manufacturing & marketing required.
- Knowledge of Therapeutic area for assigned projects.
- Experience of leading projects through Regulatory Procedures.
- Experience in Haematology/ Oncology or Inflammation/ Immunology preferred.
- Experience in clinical trial applications.
- Prior exposure to orphan drug development would be an asset.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542, or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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