Regulatory Affairs Manager Central London Lifecycle Management Post Approval
Your new company
My client is one of the leading global CROs, top 5 in terms of revenue and headcount - 15,000 employees globally and operate in over 80 countries - Partnered with Leading Global Biotech's in Oct 2016 and now have embedded teams in Regulatory operation, Clinical research and marketed products - Pride themselves on: retention, returning employees, career development, big business with small business culture
Your new role
With moderate supervision, executes on international regulatory strategies for product lifecycle, including product development and post-marketing (all therapeutic areas, biologics and small molecules). Interfaces cross-functionally within RA, as well as with Commercial, Clinical Development, Global Marketing, etc. to identify what international regulatory requirements are necessary and how to best move forward to meet project plans. Ensures execution of the strategy to ensure proper facilitation and preparation of international regulatory documents and various submissions, as well as any compliance matters; Applies a solid familiarity of international RA regulations and guidelines by applying interpersonal skills and expert RA international knowledge to address and overcome challenges that arise during development and commercialization. Successfully communicates with international Health Authorities, as necessary, with moderate supervision.
Executes the regulatory submissions to support product development and approval efforts for all post-market products (all indications) in non-US and EU countries (e.g., primarily focusing on the emerging markets including Asia Pacific, Latin America, Russia, India, etc. but also include other developed countries such as Australia, S. Africa). Where necessary, this individual will management CROs/contractor support for agreed predefined standards to meet planned project needs and ad hoc advice.Ensures country-specific regulations and local environments are in compliance to ensure the strategic direction in the development of the international component of the Regulatory Development Plan for programs are completed successfully. Stays current with revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.Works closely with functional areas throughout the company. Advises functional
areas regarding content requirements for international regulatory submissions; review documents from functional contributors for consistency and completeness. Has a solid understanding of regulatory requirements and environment for development and registration of new products particularly in the oncology arena of a
specific region such as Asia Pacific, Latin America, etc. in order to serve as a resident expert for the assigned region In coordination with other regulatory and appropriate non-regulatory staff and appropriate CROs ensures filing CTAs in all countries outside of US for investigational studies.
What you'll need to succeed
BS/BA Degree in a scientific discipline. Preferred advanced degree
(MS/PharmD/PhD).Substantial experience of directly related regulatory international
bio/pharmaceutical experience.Solid knowledge of regulations, policies, procedures, drug development
guidelines and compliance for all emerging and selected developed markets Some experience participating in meetings with Regulatory Agencies, preferred. Demonstrated leadership, problem-solving ability, flexibility and teamwork. Proven ability to provide strategic regulatory guidance to drug development,
registration and post-market support team. Good working understanding of projects in assigned area of responsibility allowing for creative and innovative solutions to address potential hurdles in
development. Strong negotiation and communication skills and the ability to work independently
and function well in a team-oriented environment are essential. Excellent written and oral communication skills required. Knowledge of eCTD.
What you'll get in return
Fantastic salary, car allowance, healthcare & pension.
What you need to do now
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