3 weeks ago

Regulatory Affairs Manager

Chertsey 70K - 75K Permanent

Job Reference: 934907

The Client

Our client is an International Regulatory Consultancy based here in the UK. Their origins can be traced back over 26 years.

They over Regulatory Services to the Pharmaceutical, Biotechnology and Medical Device industries across the globe. Including the U.S, South America, Australia, Europe and the UK & Ireland.

The business is made up of a hugely experienced team of Regulatory Affairs professionals, and due to continued growth and expansion, they now require addition experts to join and enhance the team.

The Role

With UK offices based in Surrey and West London, this is however a predominately a Work from Home opportunity, with you choosing how much/or how little you wish to work from either office. The minimum expectation being at least one day a month.

Some of your key responsibilities will include, but are not limited to:-

Regulatory drug development from early to late phase including new registrations.

The preparation of regulatory documents for EU, UK, and/or US markets e.g. regulatory strategies, briefing books for regulatory agency meetings, paediatric investigation plans, orphan drug designations.

Review clinical summaries, overviews, protocols, protocol synopses, clinical study reports and Investigator Brochures would be beneficial.

CTA and /or IND preparation, submission and management.

MAA/NDA submission process

Some involvement in regulatory risk planning and mitigation.

Involvement in development and implementation of innovative regulatory pathways to maximise success.

Continued awareness of changes in the regulatory environment.

Organise and prepare for meetings and teleconferences with key stakeholders

Interface with Commercial Teams and/or assist in business development efforts by contributing to project proposals.

The Candidate

It is likely the successful candidate will have the following:

Bachelor's degree in life sciences (minimum requirement).

Experience in regulatory affairs in a pharmaceutical company or CRO. Experience in development through to approval would be preferred.

Excellent written and oral communication skills.

Experience with orphan drugs and PIPs would be beneficial.

Demonstrated ability to work independently, with strong leadership and project management skills.

Ability to work on multiple projects simultaneously.

Competitive financial package on offer + benefits.

 

How to apply

If the above sounds like your ideal role and you have the skills and attributes as listed above, please don’t hesitate to apply today. Please email a copy of your CV in a word document format to Gareth Loveys on garethl@harrislord.com

Key words: #lifescience #regulatoryaffairs #pharmaceutical #cro

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