Our client, a large manufacturing organisation based in Sandwich, is currently looking to recruit a Regulatory Submissions Specialist to work Part time in their regulatory department.

The successful candidate will help prepare submission ready documentation for regulatory agencies and provide operational support for the regulatory portfolio for respiratory products.

This role will be initially part time, 2 - 3 days a week paying an hourly rate of £15.00 - £20.00 per hour, dependant on experience.

Duties and Responsibilities:

* Submission ready activities across the respiratory portfolio including ANDA's, NDA's, MAA's, IND's, CTA's Rest of World submissions and Agency briefing packs.
* Identify regional submission ready requirements, ensure the necessary standards are documented and play a key role in any internal procedure changes and training necessary to respond changing standards.
* Assess how the components of MGRG dossiers will comply with eCTD requirements, ensure that MGRG authors have the correct templates available for dossier development and that document control is maintained.
* Lead training for authors as required.
* Liaise with, and influence, the global and regional publishing lines in order to guarantee that quality standard of submission is made.
* Provide Project planning support for major submissions e.g. ANDAs, NDAs, MAAs.
* Assist Head of Respiratory Regulatory with product portfolio planning.
* Assist with monitoring the external competitor environment and contribute to the MGRG competitive analysis review.
* Be active in the design and development and implementation of Company Regulatory processes and procedures, where appropriate.
* Manage the day to day regulatory work to ensure that project deadlines/priorities are met.


To be the successful Regulatory Submissions Specialist

* Experienced and proven track record in regulatory affairs submissions and in an R & D environment
* Demonstrated project management, interpersonal and leadership skills.
* Detailed understanding and practical experience of building submission ready/publishing MAA's, NDA's, ANDA's etc.


Unfortunately we are currently unable to consider any speculative applications and so please do not apply for a position unless you believe yourself to be suited to the role. If you have not heard back from us within 48 hours of your application please assume that you have been unsuccessful on this occasion.