Regulatory Affairs Manager
Are you looking to propel your regulatory career?
Then this might be the role for you. We are looking for Regulatory Affairs Manager to ensure that the company acquires and maintains all the required approvals in order to support clinical trials for investigational medicinal products as well as to market approved medicinal products.
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- May manage one or more regional leads or support roles
- May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams
- Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment Knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country and International borders
- Review and approve promotional and non-promotional materials for use in the region
- Manage the product lifecycle for individual countries per national agency requirements
- Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provides content guidance for regional regulatory documents and meetings in accordance with GRT strategy
- Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and pediatric plan)
- Manages in the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Consistent with GRT strategy, advise GDT on regulatory implications and requirements related to global clinical development plans and objectives
Skills and Requirements
- Proven success in achieving regulatory approvals in the UK and /or Ireland
- Significant post-licencing experience with an in-depth working knowledge of lifecycle maintenance for pharmaceutical products, including variations and renewals
- Strong leadership capabilities with a record of proven success in managing and supervising staff
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.