Senior Regulatory Affairs Officer

Key People


Job ID :

14873


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--South West London,South West London,


Key Skills :

regulatory, regulatory affairs, generics, MAA, variation, renewal, post approval


Salary :

£40000 - £45000 per annum


Date Posted :

01 May, 2019



Company Name :

Key People


Location1 :

South West London




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

My client, a London based pharmaceutical company, are currently searching for a Regulatory Officer / Senior Officer to join their team based in South West London. Within this role you will ensure the appropriate licensing of assigned products and development projects in order to control their safety and efficacy, in line with the company business objectives, relevant regulatory requirements and internal and external standards.

Responsibilities:
Responsible for the provision of full regulatory support for assigned products across the full life cycle, from pre-launch, launch, maintenance, discontinuation and divestment. Includes the preparation and submission of licence variations, implementation of SPC and pack updates.
Manages increasingly complex submissions making decisions independently and with minimal referral to Regulatory Affairs Manager.
Interacts directly with regulatory authorities on defined matters, liaise with, and make presentations to regulatory authorities on defined matters including negotiating regarding marketing authorisations.
Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities.
Provide regulatory input on artworks and ensure approval in time for product launch and compliance with legislation and guidelines.
Maintain an up to date and developing knowledge of regulatory affairs legislation and Codes of Practice, with responsibility for completion of assigned training and own development. Apply knowledge within the sphere of own role and in support of the department's activities more widely.

Accountabilities:
Coaches more junior members of the team.
Support the PV and Medical Information function by providing assistance to ensure pharmacovigilance activities performed are completed in a timely manner ensuring compliance and mitigation of risk.
Support company Quality System, to ensure compliance with policies and procedures, and with local regulatory requirements.
Comply with relevant legal and compliance requirements, regulatory and ethical standards and company SOPs.

Qualifications and Experience:
Degree in a suitable scientific discipline (biological/chemistry/life sciences)
Basic knowledge of local and European regulatory affairs/PV legislation and guidance
Planning and organisation skills- ability to multitask
Able to work under pressure and to strict deadlines
A confident credible communicator with good negotiation skills
Good written communication skills with attention to detail.
In depth knowledge of local and European regulatory affairs/PV legislation and guidance
Substantial regulatory experience across the full product lifecycle
Broad experience of managing relevant regulatory submissions, with demonstrated ability to work independently and manage complex projects.
Able to build relationships at all levels of the business
Excellent written communication skills with attention to detail.
Ability to handle multiple tasks/projects and manage priorities accordingly.

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk


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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