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Vice President of Regulatory Affairs

Posted 12 days 9 hours ago by Quanta Consultancy Services Ltd

Permanent
Not Specified
Other
Not Specified, Ireland
Job Description
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.

Responsibilities:
  • 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.

Requirements
  • 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.
  • Proven experience and employment track record in various organisations including service provider/CRO or Consulting where you held the appropriate seniority expected for a similar role.
  • 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)

If this role is of interest, please apply now.

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