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Regulatory Affairs Executive

3 months ago

Loughborough, United Kingdom Morningside Pharmaceuticals Ltd Full time

Monday - Friday: 9.00am-6.00pm - Remote Working in India

**Are you looking to work for an award winning top 100 company in the Leicestershire area?**

**Would you like to work for a company which helps millions of people worldwide to gain access to quality and affordable healthcare?**

If so, here is your chance

Morningside Healthcare is committed to delivering quality products that help to build a brighter future. Together with our partners, we are committed to developing new, exciting therapies and increasing global access to current medications.

Morningside Healthcare has been licensing and supplying pharmaceutical products since 2001. We currently have over 100 product marketing authorisations and with a constant stream of new launches every year we are rapidly growing our presence both in the UK and global markets.

**The Role**

We are looking to recruit a Regulatory Affairs Executive within our Regulatory Affairs Team, reporting to the Head of Regulatory Affairs.

**What will you be doing?**

As the Regulatory Affairs Executive, you will be responsible for a variety of different tasks including:

- Maintaining the compliance of existing medicinal products through life cycle maintenance
- Review of product stability data for assessment of shelf-life extensions / reductions as applicable
- Compilation and update of RSIs and compliance files
- Maintenance of appropriate product trackers and folders to ensure compliance of all products responsible for, including, but not limited to, change controls, CEP, SPC, CPD, XEVMPD, product knowledge sheets
- Maintain an awareness of current regulatory requirements to advise on opportunities and threats to the Company’s Marketing Authorisations, development and regulatory strategies
- Respond to validation corrections and Requests for Further Information (RFIs) from the Competent Authorities within the defined timelines
- As required, prepare and submit regulatory compliant registration dossiers for new products to the UK, EU and RoW, liaising with appropriate technical functions and CMOs
- Maintenance of Regulatory department SOPs and WIs as required

**The Person**
- Must be able to work remotely
- At least 3 years’ experience in Regulatory Affairs.
- Relevant degree in a life science or technical discipline.
- Excellent communication skills, both verbal and written.
- Excellent organisational and time management skills.
- Good reasoning and a deductive capability.

**Why Morningside?**

Complementing your salary, we also offer a variety of benefits and services to support your physical and mental well-being which include:

- Private Healthcare scheme.
- Life Assurance
- Learning and Development opportunities.
- Excellent opportunities for progression.
- Fantastic Company events and celebrations throughout the year.

Check out the links below to explore our website and LinkedIn pages where you can find out what our employees say about working for us, other recent events inside and outside of the business: