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Vice President Quality and Risk Management
4 months ago
3 days ago Be among the first 25 applicants VP Regulatory Affairs – Remote – Life Sciences
Our client, a prominent consulting and solutions firm specialising in risk management and compliance services for the pharmaceutical industry, has been driving advancements in the development-to-market process with efficiency and innovation since 2008.
They offer comprehensive global services that cover the entire product life cycle, including Clinical, post-submission Regulatory Affairs, Pharmacovigilance, Quality Assurance, Auditing, and cutting-edge automation solutions.
Responsible for the development and growth of regulatory affairs service provision within our clients target markets and customer segments through the establishment and maintenance of Client relationships.
Responsible for business development, marketing activities and networking to support the Commercial team, thus increasing and developing new opportunities, and expanding the existing regulatory business.
Acting as an industry leader with expertise in the development of regulatory strategies for a variety of product types (Biologics, ATMPs, oncology etc.) and a demonstrated ability to assist Clients with the implementation of the most appropriate regulatory strategy for their product(s) encompassing early development, clinical development, submission, approval, and post approval regulatory activities.
Responsible for the management of the Regulatory department P&L, and delivery of agreed annual departmental goals.
15 years’ experience (or more) in Regulatory department in the life science industry
~ Post-graduate in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences
~ Proven experience with provision of strategic regulatory advice across the product lifecycle to a variety of clients, including those bringing innovative therapies to market and requiring strategic support.
~ Demonstrated ability to support clients through agency interactions with scientific committees and working parties such as those of the EMA and with national Health Authorities.
~ Proven experience with supporting Scientific Advice procedures and with Health Authority interactions throughout the product lifecycle including PRIME eligibility, Orphan Drug Designation, Pediatric Investigational Plans and Marketing Authorisation Applications.
~ Previous experience working in a leadership and people management position, ideally working with large teams across multiple locations.
~ Knowledge of Regulatory processes on the global scale, directives, regulations, and guidelines (ICH, FDA, EMA, Japan, CIS, MENA, etc)
Employment type Full-time
Job function Legal
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