Director / Head of Quality and Regulatory PermanentDo you have quality management experience within the biopharmaceutical industry?Can you perform well in a fast paced environment?Can...
- To have an in-depth scientific and regulatory knowledge of the therapeutic area and regulatory landscape in Europe, Turkey, Israel and Switzerland providing comprehensive regulatory strategies that result in increased probability of success of submissions, speed to market, and differentiated labels for products in the assigned therapeutic area.
- Lead an agile and highly effective therapeutic area regulatory team to provide best-in-class regulatory strategies and deliverables through assigned phases of development, post approval and lifecycle of the product for submissions to the European Medicines Agency and national competent authorities in Western Europe region and regulatory agencies in Turkey, Switzerland and Israel.
- Engage in and ensuring cross-functional collaboration, with affiliate regulatory colleagues, therapeutic area business and global regulatory colleagues and area and global management to drive continuous improvement seeking clarity and simplicity in implementation of processes
- Manage products and change control in compliance with regulations, company policies and procedures.
- In collaboration with global TA colleagues, leads the assigned Western Europe Regulatory Affairs TA team in the preparation and maintenance of regulatory product strategies for development and marketed products submitted to the European Medicines Agency and national competent authorities in Western Europe region and regulatory agencies in Turkey, Switzerland and Israel.
- Ensure inclusion of strategic messaging in the content of WE RA dossiers.
- Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products. Defines and effectively implements strategies in line with the changing regulatory and business needs by managing the assessment of scientific data provided by specialist units for registration (and re-r) purposes against WE regulatory requirements, identifying gaps and developing mitigation strategies and effectively assigning team membership, prioritizing resources, delegating responsibilities and follow up.
- Maintains an active awareness of EU legislation and assesses its impact on company business and R&D programmes jointly with Regulatory Policy and Intelligence. Develops and executes strategies to respond to those. May represent company for WE Area & Affiliate Strategy in industry groups and external initiatives.
- Follows budget allocations and keeps supervisor informed on project resourcing.
- Extensive pharmaceutical industry experience in Regulatory Affairs with European experience (including Israel, Turkey and Switzerland) and experience in the oncology area couple with strong therapeutic area knowledge.
- A Degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.