Reference Number: JO-2008-453330
Regulatory Publishing Manager
Job Type: Permanent
Role: Publishing Manager
Location: Stockley park or Cambridge
Salary: Highly competitive + benefits
Employment: full time, permanent
Regulatory Professionals are collaborating with a biopharmaceutical company that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi. Our client is looking for an experienced publisher to join their team in either Cambridge or Stockley park. In this role you will be managing associate level employees and you will maintain oversight and interpretation of submission requirements and guidance in allocated regions.
Other duties will include:
Joint responsibility for managing a ROW Regulatory submission publishing team. Including provision of guidance, coaching, development and performance management alongside planning and oversight of workload and resource.
Lead and / or oversee the preparation of major or complex submission compilation activities including utilization of publishing tools for electronic and paper submission generation, internal quality review and archival according to current health authority guidance, internal standards and defined timelines.
Maintain oversight and understanding of the regulatory environment, procedures, intelligence and submission standards. Providing guidance and interpretation of submission requirements for allocated regions.
Provides functional and technical guidance and or training to junior colleagues in the Regulatory Operations.
Interface with project managers, regulatory product managers, and or content authors to provide guidance on submission preparation and content and representing Regulatory Operations by taking the lead in submission planning meetings to help define company submission priorities.
Guides more junior colleagues on working with project managers, regulatory product managers, and or content authors to provide guidance on submission preparation and content.
In addition to submission compilation activities, may lead and /or contribute with the development and management of projects and initiatives as applicable in support of Regulatory Operations.
Maintains constructive and positive interactions with colleagues.
Be a subject matter expert in ROW submissions. Provide cross-functional education to partners in RA, CMC.
Be a key member of the International Regulatory Operations Leadership team, helping to identify, propose, develop and manage improvement projects that align with our clients global working philosophy.
Knowledge & Skills
Right to work in the UK
Successful candidates will be degree educated and have significant experience within a Regulatory Operations publishing environment.
This role requires expert knowledge of submission publishing tools and systems, Microsoft Word, Adobe Acrobat and Document Management Systems.
Demonstrates an in-depth knowledge of eCTD.
Demonstrates people management skills and experience and a desire to manage the performance of more junior level individuals.
Strategic thinking is required, with a focus on process improvement and optimization.
Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.
Demonstrates strong project management skills, with the ability to manage the tasks of more junior associates.
Demonstrates an ability to effectively communicate cross-functionally.
Education & Experience
Significant relevant experience and / or a BA, BS or MS.
Experience in regulatory submission publishing is required.
Experience in ROW Regulatory Operations is desirable
People management experience required
If you would like to apply for this position, please contact Amani via firstname.lastname@example.org. 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*