Senior Regulatory Affairs Officer

Salary: £54 – £66 per hour

Do you want to be part of a fast-growing, globally recognised Scientific and Regulatory company?

If you do, we want to hear from you as we have an exciting Senior Regulatory Affairs Officer within our growing Regulatory team.

Broughton Nicotine Services are a consultancy service providing analytical, scientific and regulatory support to businesses in the e-cigarettes, alternative nicotine products and nicotine-containing pharmaceutical products enabling them to increase the value of their business and advance a smoke-free future.

The Regulatory Affairs team is a group of experienced subject matter consultants that offer regulatory expertise across the full product life-cycle i.e. regulatory strategy/pathways, dossier compilation/submission and post-submission maintenance

The role of the Senior Regulatory Affairs Officer is to contribute and author high-quality regulatory submissions (eCTD, CTA, TPD, PMTA, Medical Devices) to global health authorities aligned with all applicable standards. The role holder is expected to demonstrate experience and leadership in key regulatory functions..

Main Purpose of job

As a Senior Regulatory Affairs Officer your main purpose is to author and/or lead the review of high-quality regulatory documents for global submissions and oversee the development, preparation and approval of key documents such as CTA, IMPD, IB, (e)CTD Modules and summaries, TPD and PMTA

You will work closely with the Head of Regulatory Affairs and SMEs to develop agreed regulatory strategies and pathways for clients and participate in regulatory due diligence and GAP assessments on behalf of clients.

As part of this role you will maintain an up-to-date knowledge of global regulations, providing guidance to junior colleagues, including feedback on the quality of technical documents, and assist in their training and development;

Your part in this role is to on-going regulatory advice and support to the project teams and clients whilst being able to develop and refine the regulatory function within the organisation.

Key person specification

* Pharmacy, Biological or Chemical Science degree; higher degree in one of these fields or Regulatory Affairs is preferred

* Extensive experience (5 years+) in a pharmaceutical or medical device regulatory affairs role

* Knowledge of all key regulatory pathways expected (National, MRP/DCP, Centralised, IND/NDA) alongside key regulators (MHRA, EMA, FDA for example)

* Hands-on experience in the authoring of technical sections of Marketing Authorisations (i.e. Module 3, 4 or 5 plus overall summaries)

* Exposure to ENDS, TPD and/or PMTA would be highly desirable.

* Proficiency with a wide range of information (CMC, clinical, non-clinical, manufacturing etc)

* Experience of post-approval activities would be welcome.

* Ability to engage across multiple work-streams and liaise with all stakeholders to achieve project deliverables.

* Excellent communication skills, written and verbal.

* Ability to help drive and shape the Department going forward.