Head of Regulatory Affairs - Deeside, United Kingdom - Reacta Healthcare

Reacta Healthcare

Verified Company

Deeside, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Role:
Head of Regulatory Affairs**
Location:Deeside, CH5 (with hybrid option)**
Salary:circa £100k**
Benefits Package:Private Health Insurance, Life Assurance,
Potential for future Share Options, Enhanced Annual Leave, Enhanced Pension Contributions

The Company:

Reacta Healthcare, established in 2013, operates from a pharmaceutical manufacturing facility in Deeside, North Wales.

It is licenced to manufacture challenge meals for use in clinical trials.

These challenge meals are currently used to diagnose and monitor food allergy in numerous worldwide therapeutic trials.

Patents for the challenge meals have been granted in a number of countries.

Reacta Healthcare is developing its in-house analytical capability and has plans in place for expansion into niche areas of food allergen development and manufacture.

This will include all aspects from sourcing through to manufacture of end product.

The Opportunity:

Reacta Healthcare are a young, entrepreneurial, and fast-growing organisation, positioned for great things As a result of this continued, exponential growth Reacta are now looking to recruit a Head of Regulatory Affairs.

This hands-on role is a unique opportunity to be an integral part of the success story.

A key role as part of the Senior Leadership Team, the Head of Regulatory Affairs will have the opportunity to develop the function from scratch, supported by our internal teams and external consultants where appropriate.

The role includes the following key accountabilities:

Key Accountabilities

Plan and execute regulatory strategy for new products to ensure the fastest possible introduction of that product to the market.
Ensure that all information provided in submissions is correct, of a high standard, complies with regulatory requirements and is presented in a professional manner.
Ensure the regulatory compliance of the company for any IMPD/IND, manufacturing, or other authorisations.
Provide advice on all regulatory matters to internal and external stakeholders.
Advise on regulatory requirements to support the growth of the business.
Respond to questions raised by global regulatory authorities and customers, working closely with colleagues to obtain the relevant information to compile the response.
Ensure that all required pharmacovigilance activities are in place to support the use of the product(s)
Maintain up to date knowledge to support the business, for example, by monitoring legislation and professional publications to maintain awareness of current regulatory practice.
Manage external consultants to ensure the timely completion of any outsourced activities.
Essential Skills, Qualifications and Experience

To be successful in this role, applicants need to have the following essential skills and experience:

An understanding of all relevant aspects of the pharmaceutical industry.
Exceptional eye for detail.
Educated to Degree level in a life science

Desirable Skills and Experience

Knowledge of the regulation of medical devices
Membership of The Organisation for Professionals in Regulatory Affairs (TOPRA)

Do you want to feel inspired every day? We are future-focused, and our business is growing rapidly. We succeed together through passion, commitment, and teamwork, and so can you.