Senior Regulatory Officer Team Lead

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I'm currently working with a global specialty and branded multinational pharmaceutical company with a presence in both emerging and developed markets. Who have approximately 9 800 employees at 71 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable products. They are currently looking for Senior Regulatory Affairs Team Lead to join their RA team.

What will I be doing as a Senior Regulatory Affairs Team Lead?Working within an environment with an international outlook, manage the team of Regulatory Affairs Officers and submissions process for MRP/DCP procedures, achieving long term account goals in line with the company vision and valuesManage and oversee the coordination of regulatory submissions assigned to RA International Submissions Team and ensure registration deadlines are metManage and oversee the coordination of regulatory submissions assigned to RA International Submissions Team and ensure registration deadlines are metEnsure that documentation compiled by team is complete and complies with applicable regulatory requirementsEnsuring that information is exchanged and weekly and monthly reporting is followed by the RA International Submissions TeamTracking submission progress through efficient communication to relevant entities/stakeholders and local service providersClose cooperation and communication with other entities/departments in order to obtain timely product approvals.Assist in the development of regulatory strategy as well as monitoring the impact of the changing regulatory environment on submission strategies.Proactively inform the RA Manager and other involved functions regarding all identified risks related to the planned MAA.Submit Marketing Authorisation Applications (MAA) to Health Authorities according to the registration plan and company's registration strategy.Obtain scientific advice from Health Authorities by liaising with the Health Authorities and preparation of all the required documents.Prepare expert report (CMC part of dossier) and Quality Overall Summary.Compile the hard copy and/or eCTD of the registration dossier (depending on specific in-country registration requirements.Identify and then obtain any deficient information in order to complete the compilation within the allocated time frame.Prepare, as per internal process, the data needed to make all required registration fees in a timely manner.Dispatch the documentation in the appropriate manner in order to deliver it to the relevant Health Authority or local Regulatory Service Provider or local Marketing Authorisation Holder (MAH); ensure the delivery is confirmed.Answer all queries received from Health Authorities during the validation phase of registration.Ensure all internal RA database are updated with any new specific national requirements.What do I need to be Senior Regulatory Affairs Team Lead?Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degreeMin 4-5 year experience in a regulatory affairs environment in the pharmaceutical industry preferably with management/supervisory experienceDetailed knowledge of EU current registration requirements for dossier preparation and procedure runningSolid knowledge of specific national requirements in EU and other regionsKnowledge of IT tools specific for in RA and pharmaceutical sector (e.g. eCTD, databases, change control management etc.)If you'd like to discuss the chance of becoming Senior Regulatory Affairs Team Lead , please send across your current CV and we can have a confidential conversation about this opportunity. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales