Regulatory Affairs Associate

Key People

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Job ID :

14233


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Berkshire,Berkshire,


Key Skills :

pharmaceutical, regulatory, variations, renewals, MA's, MHRA, NP


Salary :

£20000 - £25000 per annum


Date Posted :

12 Feb, 2019



Company Name :

Key People


Location1 :

Berkshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Responsibilities
*Help with the preparation and submission of applications of reliable quality in a timely manner to MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
*Work with QPPV on PSUR submissions, update SmPC and labelling against the Company Core Data sheets.
*Liaise with regulatory authorities for advice and guidance where applicable, and to solve issues to reach the best possible outcome for the business.
*Keep up-to-date records and documentation in respect to Marketing Authorisations.
*Execute duties in line with regulatory, commercial, quality and business needs and make sure of compliance with regulatory legislation and guidelines, and company processes and procedures.
*Provide help to other regulatory staff members within the Company when necessary.
*Any other task given to you by relevant stakeholder in order for you to be able to carry out your position

Required Skills
*Must have a 2:1 or above in either a Pharmacy, Chemistry or similarly analytical related degree
*1 years' experience in the pharmaceutical industry or related field although


Graduates are welcome to apply
*A basic comprehension of the current UK and European regulations, laws, guidelines and industry requirements is preferable but not necessary.
*Attention to detail to make sure of the quality of documentation.

Additional Experience
*Effective oral and written communication skills
*Excellent organisational and planning skills
*Ability to work independently
*Ability to interpret data
*Strong interpersonal skills; ability to develop and maintain cooperative working relationships with others and work in a team-based environment.
*Ability to use good judgment in order to carry out detailed instructions.
*Basic problem-solving capabilities
*Strong computer skills (including but not limited to Word, Excel, Powerpoint, Office 365).
*Ability to demonstrate calm objectivity in an intense, results driven environment, whilst successfully dealing with often changing and conflicting priorities


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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