Regulatory Affairs Associate
, 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
, 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.
, 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
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