Labeling strategist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Regulatory Affairs Associate Director- Labeling strategist – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As Regulatory Affairs Associate Director- Labeling strategist you will be leading global labeling strategy and author key documents—such as the Target Product Label (TPL), Company Core Data Sheet, Core Instruction for Use, prescribing information (PI), and patient information—for both new and registered assets within regulatory affairs and in cross-functional teams.

As part of our global team, you’ll have the opportunity to lead innovative projects and provide strategic regulatory intelligence that makes a real difference in product development. As a Regulatory Affairs Associate Director, you'll play a key role in guiding product development from preclinical stages through registration and optimization. You will provide regulatory expertise and client interface, offering strategic guidance and updates on country, regional, and global regulatory intelligence. Routinely act as an adviser to other units within the department and liaise with local country regulatory authorities. Responsible for acting as a liaison with internal and external clients in the provision and marketing of these services.

What You’ll Do:

• Define and monitor authoring plan with Global Regulatory Lead (GRL) and Project Manager(s).

• Lead the labeling strategy in cross functional teams (including US, EU, JP regulatory regional leads) based on target product profile, competitor review, label and regulatory intelligence, regulations, development data … etc.

• Author target product label (TPL) for the strategic contents of the label

• Lead and document labeling working group (LWG) and global labeling committee (GLC) for the assigned projects.

• Attend and contribute to Global Regulatory Team (GRT) and submission teams.

• Collaborate with GRL to provide labeling contribution in development governance or project teams as needed

• Review and contribute, as needed, to source documents of the label including HA consultation requests and responses, clinical study (CS) concept sheets, CS protocols and reports, pharmacy manual, statistical plan, device development material, development IFU, human factor study protocols and reports, eCTD modules, signal evaluation reports, PBRER … etc.

• Author the Core Company Data Sheet and core IFU and, in collaboration with Labeling Operation Manager, global labeling implementation plan.

• Author the US label (PI, PPI, IFU) and supervise US mock-ups and SPL activity managed by the Labeling Operation Manager.

• Evaluate global and US labeling impact assessment of any queries of label update and assist, as needed, the Labeling Operation Manager with recording these assessments in the databases.

• Assist Regulatory Regional Leads with local dossier preparation for CCDS update and responses to Health Authority questions, involving the Labeling Operation Manager as appropriate based on the level of complexity.

• Support, as needed, Labeling Operation Manager and Regulatory Operations in publishing the labeling section (1.14) of US eCTD dossier.

• Serve as GLC Chairperson, providing oversight of GLC requests from other labeling strategists or Regulatory Regional Leads, with the support of Labeling Operations Managers.

• Act as global labeling expert in Safety Management Team

• Supervise the labeling contribution to PSUR/PBRER, PSMF, US annual report and other regulatory procedures managed by Labeling Operations Managers.

• Offer specialized labeling expertise in Labeling Operation Projects as requested by Labeling Operation Managers.

• Create, contribute and maintain procedures or equivalent related to labeling activity.

• Participate in PV inspector or auditor interviews

Acts as a global lead in providing review and technical advice to prepare regional and/or global regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.

Acts as lead subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects. Provides internal clients with up-to-date legislation and guidance as it becomes available.

Ensures quality performance for key/managed projects.

Manages project budgeting/forecasting functions.

Identifies and recognizes out of scope ac