An exciting new opportunity has arisen for a Regulatory Affairs Associate to join my client, a growing pharmaceutical company based in Berkshire. This role will suit a regulatory professional at the beginning of their career – please note that 6 months to 1 year of regulatory experience is required.
++ Please note that this role is fully office based (5 days per week) and hybrid working is not available ++
Responsibilities:
Assist with the preparation and submission of applications in a timely manner to the 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 in line with the Company Core Data sheets. Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business. Maintain up-to-date records and documentation in relation to Marketing Authorisations. Carry out duties in line with regulatory, commercial, quality and business needs and ensure compliance with regulatory legislation and guidelines, and company processes and procedures. Support other regulatory staff members within the Company when necessary. Required Skills:
Must have a 2:1 or above in either Pharmacy, Chemistry or similarly analytical related degree. 6 months – 1 year+ of regulatory experience is required. Effective oral and written communication skills. Ability to demonstrate calm objectivity in a results-driven environment, whilst successfully dealing with often changing and conflicting priorities.
#J-18808-Ljbffr
Assist with the preparation and submission of applications in a timely manner to the 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 in line with the Company Core Data sheets. Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business. Maintain up-to-date records and documentation in relation to Marketing Authorisations. Carry out duties in line with regulatory, commercial, quality and business needs and ensure compliance with regulatory legislation and guidelines, and company processes and procedures. Support other regulatory staff members within the Company when necessary. Required Skills:
Must have a 2:1 or above in either Pharmacy, Chemistry or similarly analytical related degree. 6 months – 1 year+ of regulatory experience is required. Effective oral and written communication skills. Ability to demonstrate calm objectivity in a results-driven environment, whilst successfully dealing with often changing and conflicting priorities.
#J-18808-Ljbffr
