Regulatory Affairs Manager in Manchester

Location: Manchester Area

Salary: Hidden

Recruiter: Purple Carrot Recruitment

Job Hours: Full-time

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Regulatory Affairs Manager (12m FTC) – Leading Pharma Specialist Medicines – Manchester (hybrid working) - £competitive salary, 10% bonus, pension + other benefits.

The Company

Market leader in specialist medicines for children

Stylish offices in Manchester city centre, they offer a hybrid working policy (2/3days per week in the office), whereby you can expect perks such a dog friendly office, wellness room and a barista service.
Operate mainly on a UK/EU basis however there is some US exposure as well.
Active pipeline within CV, Immunology and Neurology as well as an exploratory pipeline in Gastro and Oncology.

The Role

Provide regulatory support for all activities conducted by the Company including dossier compilation, variations, change impact assessment, scientific advice applications, paediatric investigation plans, PSUR submissions.
To manage the generation and maintenance of Registration Dossiers (MAA/CTD) related with the products manufactured, in compliance with applicable legislations.
To develop the regulatory strategy for new submissions.
Working on EU projects within centralised procedures

You

Ideally 5 years’ experience (or equivalent) working in Pharma Regulatory Affairs
Experience of the centralised procedure for new products (EMA).
Working knowledge of the Common Technical Document (CTD).
Experience of directly dealing with Regulatory agencies.
Experience of scientific advice, paediatric (Paediatric Investigation Plan) or Orphan procedures is highly desired but not essential.
Experience in gaining and maintaining product licences in the USA is desired but not essential.

What should you do next?

This Regulatory Affairs Manager role is one not to be missed; it encompasses the opportunity to work with a hugely innovative pharmaceutical company.

To discuss this role further or to find out about other roles I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we'll be more than happy to assist.

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Permanent chef recruitment and interim chef cover throughout the country

Few people understand what it takes to work in a professional kitchen. The hours, commitment, and passion required to be part of a tight knit team; that every kitchen is different and picking the right candidate for a team is vital to making sure service runs smoothly. Whether it is front of house or in
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Boasting decades of experience, not as recruitment consultants but as chefs, Purple Carrot know what it takes. Just like getting the balance right in a meal, we understand how important it is to match the right person to the right role. From commis chef through to general managers, we know
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