Regulatory Affairs Senior Manager – Global Pharma – Berkshire with hybrid working - £negotiable DoE, bonus & benefits
My client is a global pharmaceutical company specialising in the development, production, and marketing of a wide range of pharmaceutical products. Their focus areas include Generics, Branded Formulations and Speciality Drugs covering a wide range of therapy areas on a global basis.
Define regulatory strategy and provide guidance on regulatory requirements for new product development
Scientific advice preparation and meetings, review and submission of generic, hybrid and full MAs to European health authorities through National, CP, DCP or MR procedures.
Support the lifecycle management of existing products.
Regulatory Strategy: Deep understanding of European regulatory requirements, with experience in developing regulatory strategies for both generic and specialty products in the EU
Leading regulatory processes from strategy design to marketing authorisation (MA).
Lifecycle Management: Managing product lifecycle activities, including marketing authorisation submissions, post-approval line extensions, variation strategies, and regulatory approvals (e.g., Proven track record in managing regulatory procedures to secure timely product approvals.
This Regulatory Affairs Senior Manager role is one not to be missed; it encompasses the opportunity to work with a leading Generics Pharmaceutical company To discuss this role further or to find out about other roles I’m currently working on, please get in touch or hit apply to submit your current CV.