Regulatory Labeling Manager

Job Description

Job Description

Job Title: Associate Director, Global RA Labeling Lead

Location: Cambridge, MA 02142

Duration: 6 months

Hybrid role – Candidate Must be Local

Job Description:

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. There are two main drivers of innovation that are the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision Medicine

• The Global Regulatory Labelling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labelling and works under the direction of the Head of Global Labelling and is:
• Responsible, with minimal supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific,
• Commercial, to ensure successful development and maintenance of Labelling managed within
• PDT BU’s Global Labelling function, pertaining to pharmaceutical drug and device.
• Ensuring that there is strategic Labelling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans.
• Formulating regulatory Labelling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.
• Providing expert advice on current Labelling requirements, templates, tools, and Health Authority-issued guidance pertaining to pharmaceutical drug and device.

Accountabilities

• Drives Labelling strategy for the PDT BU via the development and lifecycle management of the CCDS, US, and EU labels.
• Formulates and implements innovative regulatory strategies for Labelling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion.
• Prepares strategic Labelling vision for early development programs and gains alignment from internal stakeholders.
• Draws on Labelling precedent, Health Authority feedback, and guidance, to create innovative Labelling strategies.
• Provides guidance on combination product/drug-device Labelling.
• Interprets scientific and clinical data and leads development of Labelling to optimize product potential and patient benefit-risk ratio.
• Introduces creative solutions for data presentation and gains consensus by Labelling teams to meet the requirements of the Health Authorities
• Prepares backup strategies in support of Labelling negotiations.
• Takes initiative in leading global Labelling team and cross-functional projects.
• Leads CCDS, US, and EU Labelling Teams in the development and maintenance of Labelling.
• Actively engages cross-functional Labelling stakeholders to gain consensus on Labelling strategy.
• Effectively identifies and resolves conflicts/issues to reach Labelling decisions with minimal escalation to management for dispute resolution.
• Liaises with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining to Labelling and communicates the impact on the PDT BU products.
• Provides guidance to Regulatory affiliates as necessary in assessment of Labelling changes to ensure timely implementation.

Dimensions And Aspects

• In close collaboration with the Client R&D Labelling function, oversees the direction, management and implementation of the Labelling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory Labelling guidance.
• Project manages new or updated Labelling to ensure compliance with internal procedural or Health Authority submission timelines.
• Manages and facilitates review of CCDSs and regional Labelling, as appropriate, via the Labelling Team and executive governance committees for PDT BU products.
• Prepares final proposed Labelling for review by the Labelling Team and approval by the executive governance committees, as appropriate, prior to internal approval and/or submission to health authorities.
• Manages the preparation of submission-ready Labelling components, consults with affiliates on Health Authority communications regarding Labelling.
• Ensures internal and external stakeholder awareness of proposed and newly approved Labelling changes, as required.
• Ensures compliant version control of product Labelling and other related documentation within the Client document management systems.
• Ensures QC of CCDSs and other Labelling documents.
• Updates Labelling decision records to ensure Labelling history is appropriately tracked and archived.
• Ensures Client employee awareness of, and adherence to, Client Labelling processes via regulatory training.
• Designs and delivers Labelling training programs.
• Documents Labelling tracking information as required in end-to-end tracking systems to facilitate overall compliance and oversight of Labelling activities

Leadership

• Ability to motivate, mentor and manage diverse cross functional teams
• Global perspective with a demonstrated ability to work across functions, regions, and cultures
• Ability to identify potential challenges and opportunities and make recommendations
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company
• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviours for the organization
• Invests in helping others learn and succeed
• Able to influence without authority at senior level (TET/TET-1, GLOC)
• Demonstrates agile leadership by seeking to understand with the ability to evolve ideas as needed.
• Interviews, mentors, and develops employees/consultants.
• Builds and enhances strategic, cross-functional, stakeholder relationships through thoughtful engagement and leadership (including, the planning, assigning, and direction of work).

Decision-Making And Autonomy

• Accountable for acting decisively and exercise sound judgment in making decisions with limited information
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence
• High ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities
• High ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution
• Develops executable plans and meets budget and deadlines
• Builds a culture of data driven decisions
• High ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.
• Crisp decision-making following appropriate consultation, even in times of ambiguity.
• Self-starter. Demonstrates initiative in advancing strategic projects with minimal guidance.

Interaction

• Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU
• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions
• Strong communicator, able to persuasively convey ideas verbally and in writing
• Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk-taking)
• Disruptive thinker with the ability to influence and change how R&D used data to make decisions and set priorities
• Continuously challenging the status quo and bringing forward innovative solutions
• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

Complexity

• Delivers solutions to abstract problems across functional areas of the business.
• Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.
• Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through influencing skills.
• Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity
• Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy
• Resilient and comfortable working through large scale global change management
• Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU and international markets.

Education And Experience Requirements

• Minimum of 7-10 years of experience in the biopharmaceutical industry (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.). 5-7 years of direct experience in a global, US, or EU Labelling role is desired.
• Experience in plasma-derived therapies and biologics preferred.
• Bachelor’s or master’s degree required. Advanced scientific or health sciences degree or equivalent relevant experience preferred.
• Previous leadership experience and management of direct reports preferred.
• Must have a detailed understanding of pharmaceutical drug and device development and global regulations pertaining to Labelling, specifically, EU and US Labelling requirements and guidance. Combination product/drug-device Labelling knowledge is preferred. Advertising and promotion knowledge is a plus.
• Expertise in the development and maintenance of the Company Core Data Sheet, the USPI, and the EU SmPC.
• Understanding of SPL format, requirements and guidance for legacy and PLR labels.
• Proficiency in Electronic Document Management Systems and End-to-End (E2E) Labelling Tracking Systems to support Labelling documentation, tracking, and compliance activities.