Senior Regulatory Manager

Employer
Regulatory Professionals
Location
Cambridge
Closing date
9 Oct 2020

View more

Discipline
Regulatory Affairs, CMC
Hours
Full Time
Contract Type
Permanent
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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.

Main responsibilities:
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

Requirements:
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*

Every member of our team is committed to delivering the highest level of service. This translates to offering consistent and exceptional service to each and every candidate we work with. Working in cooperation and partnership our aim is to build trust through consistent delivery, to keep our promises and to exceed expectations.

Our teams are experts in their pharmaceutical markets, both geographically and technically. As we fully understand each of the pharmaceutical sectors we work within, we can be flexible in our approach to matching candidate expectations, finding the right position in the best location. With coverage across nine European Markets via our Multilingual International hub in central London we can offer expert technical knowledge with local understanding.

 

 

Contact Us
  • 33 Blagrave Street
  • Reading
  • RG1 1PW
  • GB
  • +44 (0)118 9522 797
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