Labeling strategist - Reg Affairs AD

Work Schedule

Environmental Conditions

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 activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.
• Oversees matrix/project leadership, training and guidance to junior team members.
• Ensures compliance with relevant organizational and department SOPs and WPDs.
• Participates in and leads launch meetings, review meetings and project team
meetings. Leads departmental initiatives/project teams.

Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

• At least 5 years of experience in global labeling strategy
• Prior experience in biologic products, medical devices, combined products.
• Prior experience in clinical development and/or global regulatory affairs environment.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Deep knowledge of clinical development and experience in how labeling connects clinical, commercial, and market access teams.

• Deep knowledge of the entire end-to-end labeling process during labeling maintenance, including how labeling connects clinical development, pharmacovigilance, medical affairs, commercial, CMC regulatory, Global/regional regulatory, quality, and supply chain teams.

• Knowledge of eCTD dossier and labeling content.
• Knowledge of labeling compliance management
• Deep knowledge of regulatory, labeling and clinical intelligence databases (e.g. Dr evidence, FDA website, EMA website, clinicaltrial.gov…)
• Knowledge of electronic tools such as Regulatory Information Management Systems, Electronic Document Management System (e.g. Veeva Vault), Adobe Acrobat Pro
• Detail oriented and well organized
• Active listening, understanding constraints from other discipline.
• Critical thinking: using logic and reasoning to identify the strength and weaknesses of alternative solutions, conclusions or approached to problems.
• Active learning: understanding the implications of new information for both current and future problem-solving and decision-making.
• Analytical skills: decision taking based on facts and figures rather than on assumptions.
• Team player who seeks to help and learn from colleagues.
• High learning attitude and adaptability.

• Mastery of English language (written and oral) communication skills as well as local language where applicable
• Exceptional attention to detail and quality as well as outstanding editorial/proofreading skills
• Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Effective organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Professional negotiation skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
• Advanced understanding of medical terminology, statistical concepts, and guidelines
• Outstanding analytical, investigative and problem-solving skills
• Excellent understanding of budgeting and forecasting
• Sharp executive presence and consultation and presentation skills

Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.