RA Project Manager (Fully Home-Based)

Job title : RA Project Manager (Fully Home-Based)
Location : England
Job type : Permanent
Salary : Negotiable
Contact name : John Spring
Contact number : +44 (0) 207 255 6650
Contact email : john.spring@secpharma.com
RA Project Manager (fully home-based)

This role is a great opportunity for an experienced Regulatory Affairs Project Manager to join a fast-growing pharmaceutical company specialising in the treatment of chronic hormonal conditions. The position will offer you access to a range of responsibilities and career development within a field with unmet medical need. This role plays a key part in the company's RA operation, covering clinical trial documentation through to post-marketing and healthcare authority meetings.

Salary & Benefits:

£45k + benefits (full details on request)

Role and responsibilities:

*Involvement in regulatory interactions with regard to maintenance/application of CTAs, INDAs, life-cycle management and pre/post-marketing documents
*Involvement in regulatory meetings with regulatory agencies such as MHRA, EMA and FDA
*Preparing documents for registration and submission of MAAs/NDAs in compliance with the requirements of regulatory authorities
*Interaction with CRO partners, facilitating MAA submissions
*Prepare product information (including artwork/labelling) and ensure that all manufacturer and importer/wholesaler licences are maintained
*Supporting the Head of RA for development planning of the company's lead products and other products in development
*Apply compliance across GxP throughout the business

Requires skills and qualifications:

*Degree in a relevant field such as biomedical sciences or similar
*Solid industry experience (2-5 years) in Regulatory Affairs within the pharmaceutical industry, covering both clinical trial and marketing authorisation approvals
*Strong project focus and ability to work individually as well as part of a team
*Experience with submission portals for EU and US nice to have
*Excellent communication skills

This position offers a great variation of responsibilities, giving full access across the life-cycle of the company's pipeline of interesting products. You can grow your career at this company and accelerate your development in clinical trials and post-marketing RA activity.

To apply for this position and put yourself under immediate consideration, send your CV to john.spring@secpharma.com or call +44 (0) 207 255 6650