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Regulatory EMEA Submission Manager

Location: High Wycombe, Buckinghamshire Salary: £35.00 - £43.50 per hour
Sector: Pharmaceuticals Specialism:
Type: Contract Contact: Matt Henocq

Description:

This position is responsible for the management and delivery of regulatory submissions to global health authorities required to support the maintenance, development and registration of products. Depending on the particular project and assigned submission(s), required activities may include, but may not be limited to:


. Establishing Dossier Plans for the assigned Global submission types as needed to support the lifecycle of one or more products.

. The candidate will be responsible for: generating dossier plans that will reflect inputs from functional area representatives and key stakeholders, meeting regularly with submission stakeholders and cross-functional representatives to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs.
. Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate.
. Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable, tracking submission events/activities in appropriate systems/tools.
. Support development of departmental work practices, process enhancements, and associated training materials.
. Develop/maintain associated process tools and relevant training documentation.
. Support compliance needs as appropriate.
. Apply appropriate regulatory submission standards, requirements, processes and policies to comply with applicable health agency requirements;

. Maintain open, timely and effective communications with all publishing contributors and responsible RA professional, to ensure timely delivery of dossier components and/or complete dossier for submission;

. Participate on special projects and process improvement initiatives, as needed.


Qualifications:
. Bachelor's Degree or equivalent experience required; A minimum of 6 years of professional experience required; A minimum of 3 years of Regulatory Affairs experience required;

. Experience associated with managing or publishing of global regulatory submissions, including EMA (National, MRP and CTAs), EMEA Emerging Markets and FDA is required;

. Therapeutic area and product knowledge, understanding of drug development process preferred;

. Demonstrated project or submission management capabilities preferred;

. Demonstrated effective interpersonal, teamwork, and communication skills required;

. Ability to exercise solid judgment and communicate effectively with varied levels of the organization required;

. Ability to work in a matrix environment required; Demonstrated ability to build productive relationships across an organization required;

. Knowledge of relevant submission-related Health Authority and Industry regulations and guidelines required; Problem solving capability, including trouble shooting and adaptability required; Ability to use Regulatory Information systems.

This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for an interview. A copy of our privacy policy can be found here: https://www.goldgroup.co.uk/about-us/privacy-policy. Gold Group is an equal opportunity & diversity employer. A copy of our equal opportunity & diversity policy can be found here: https://www.goldgroup.co.uk/about-us/equality-and-diversity-policy