Senior Pharmacovigilance Consultant
- EU/UK/IE Regulatory
- Lifecycle Management
- Product Information
- OTC medicines, medical devices & cosmetics
- Claims & Copy review and approval
- Project Management
Becky has 9 years experience working within regulatory affairs, with 7 years experience within an OTC UK/Ireland affiliate and has experience spanning pre-registration through to post-approval across the DCP/MRP and National procedures.
Prior to joining BlueReg Pharma Consulting, Becky has held various positions within regulatory affairs within the OTC and biotech arenas. She has several years experience within line management and has extensive project management experience.
Becky started her regulatory career in 2009 working for Wyeth Pharmaceuticals which later became Pfizer, where she was responsible for coordinating post approval submissions in 110 markets, including centralised and DC procedures in the EU. She supported a move to an electronic submission system and developed a procedure for dossier compliance review.
In 2011 Becky joined Johnson & Johnson consumer healthcare and worked with OTC products in all aspects of post-approval regulatory, and additionally provided local market support and copy clearance for cosmetics and medical devices. Projects included reclassification, national MA applications and several new product launches across all project types.
In 2014 she joined RB UK where she was responsible for all regulatory activities in her categories and worked on National/DC/MR Procedure submissions and a large portfolio of medical devices and cosmetic products. She completed due diligence activities and launched several new products. Additional responsibilities included SOP authoring and review, mentoring and line management.
In 2016 Becky moved to Omega Pharma where she was responsible for a team of regulatory associates and senior associates, and all activities for pre and post approval activities for a number of OTC categories, including National/MRP/DCP/THR submissions and medical devices. This included claim development, copy review and approval covering ABPI, PAGB, IPHA, CAP and BCAP codes. Additional responsibilities included some local quality and pharmacovigilance actives and audit support.
In January 2018, Becky moved to BlueReg Pharma Consulting.