Senior Regulatory Affairs Officer - LCM

28 Nov 2018
28 Jan 2019
Regulatory Affairs, CMC

Technical Skills/Experience

Degree in life science-related discipline or professional equivalent

Minimum of 5 years in international regulatory lifecycle maintenance experience, focusing on marketed products

Experience in regulatory procedures in Europe and/or emerging markets (e.g. variations/renewals/new MAA submissions)
to support marketing authorisation activities

Good understanding of pharmacovigilance activities relevant to marketed products

Experience in managing regulatory projects

Interaction with Regulatory Agencies (EU/EMA)

Involvement in regulatory strategy and determination of documentation requirements, timelines, budgets

Preparation of relevant CTD documents to support submissions (mainly Module 1), in collaboration with technical/CMC/Labelling experts

Experience in quality review of technical/ regulatory documents

Able to mentor junior colleagues and to assist in their training and development as appropriate

Able to assist in review and revision of regulatory SOPs / act as reviewer as appropriate


Soft Skills

Excellent verbal and written communication skills, proficient English skills are essential

Be able to manage peaks of workload and prioritise workload with minimal supervision

Ability to work to tight timelines

Open and communicative personality

Good team player

Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach

Strong computer skills, including MS Office applications, data and document management systems

Adaptable to change

Cultural awareness

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