Reference Number: JO-2009-454633
Senior Regulatory Manager
Job Type: Permanent
Role: Senior Regulatory Manager
Location: Cambridge (home working offered)
Salary: highly competitive + bonus
Employment: full time, permanent
Regulatory Professionals are collaborating a growing pharmaceutical company which mainly markets products for treatment in oncology. Our client is looking for a Regulatory Affair professional who can be involved in preparing and maintaining clinical trial applications in support of our clients development programmes around the world. This position is a hands-on clinical trial role with the opportunity to take on more responsibility in the future.
Responsible for the oversight and coordination of the Regulatory Affairs CTG workload.
Responsible for coordinating monthly and ad hoc status reports.
Senior RA representative in the CTG, to provide regional SME expertise to the group and cross functionally within our client. Lead on significant CT related initiatives.
Responsible for the preparation of clinical trial application regulatory submissions in compli-ance with global requirements. These will include EU documents such as initial CTAs and their accompanying IMPD, as well study/IMPD amendments, global documents such as IB updates and US documents such as IND safety report submissions.
Review and approve CTA related regulatory submissions, and support compliance check of regulatory approvals being in place prior to study site initiations and investigational product being provided.
Define and implement submission plans in conjunction with regulatory PT lead, clinical trial sub-team members, and participate in sub-team meetings to provide regulatory expertise and status updates.
Represent RA at clinical trial sub team meetings, identify needs and issues to the cross func-tional team.
Liaise with CRO regulatory contact, managing information/document needs and exchanges, agree upon submission strategy, ensuring the CRO is clear upon our client deadline expecta-tions.
Utilise CRO regulatory contacts to seek regulatory intelligence that will be beneficial to our cli-ent sub team discussions and strategy, maintaining regulatory relationships with counterparts.
Contribute to quality management, implementation of best practices and SOPS for CTA related activities.
Work with cross-functional team members to resolve issues raised either internally or by Health Authorities to ensure a rapid and efficient resolution.
As a member of the global regulatory affairs team, contribute to process improvements, and inspection readiness amongst the department.
Maintain up to date knowledge of CTA related regulatory requirements and communicate in a
Right to work in the EU
Requires a Life Science/Pharmacy degree in a relevant discipline
An advanced degree (MSc/PhD) is desirable
Minimum of 6 years of global regulatory CT related experience is required.
If you would like to apply for this position, please contact Amani via amani.yousef@Regulatoryprofessionals.com.
If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*