Associate Director Regulatory Labeling

Discover International; Cambridge (MA); On-site; USD 150,000 - 230,000; Full time

Job summary

Discover International is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to guide strategic labeling and ensure regulatory compliance for plasma-derived therapies. You will influence internal stakeholders across Clinical, Pharmacovigilance, Legal, Scientific and Commercial teams to support labeling for drug and device products.

You will drive CCDS, USPI and regional labeling, align with Health Authority expectations, and lead global labeling teams to optimize patient

Qualifications

• Requires deep knowledge of regulatory labeling requirements for drug and device products.
• Experience leading labeling strategy development and lifecycle management.
• Proven ability to collaborate with clinical, pharmacovigilance, legal and commercial teams.

Responsibilities

• Lead global labeling strategy for PDT BU across US, EU and other markets.
• Develop and implement innovative labeling strategies to support product development and commercialization.
• Oversee CCDS, USPI and EU SmPC labeling processes and governance.
• Provide guidance on regulatory labeling trends, templates, and Health Authority expectations.
• Mentor and lead cross-functional labeling teams and projects.

Skills

Regulatory strategy

Labeling expertise

Cross-functional leadership

Stakeholder management

US/EU labeling guidance

Education

Bachelor's or Master's degree

Advanced degree in science/health

Tools

EDMS systems

SPL format

Labeling tracking systems

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 Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling 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 labeling managed within

PDT BU’s Global Labeling function, pertaining to pharmaceutical drug and device.

Ensuring that there is strategic labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans.

Formulating regulatory labeling 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 labeling requirements, templates, tools, and Health Author-

ity-issued guidance pertaining to pharmaceutical drug and device.

ACCOUNTABILITIES

Drives labeling 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 labeling development to sup-

port successful commercialization of developmental products and enhance opportunity for mar-

keted products and global expansion.

Prepares strategic labeling vision for early development programs and gains alignment from

internal stakeholders.

Draws on labeling precedent, Health Authority feedback, and guidance, to create innovative

labeling strategies.

Provides guidance on combination product/drug-device labeling.

Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio.

Introduces creative solutions for data presentation and gains consensus by labeling teams to

meet the requirements of the Health Authorities

Prepares backup strategies in support of labeling negotiations.

Takes initiative in leading global labeling team and cross-functional projects.

Leads CCDS, US, and EU Labeling Teams in the development and maintenance of labeling.

Actively engages cross-functional labeling stakeholders to gain consensus on labeling strategy.

Effectively identifies and resolves conflicts/issues to reach labeling decisions with minimal es-

calation to management for dispute resolution.

Liaises with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining

to labeling and communicates the impact on the PDT BU products.

Provides guidance to Regulatory affiliates as necessary in assessment of labeling changes to

ensure timely implementation.

DIMENSIONS AND ASPECTS

In close collaboration with the Takeda R&D labeling function, oversees the direction, manage-

ment and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regu-

latory labeling guidance.

Project manages new or updated labeling to ensure compliance with internal procedural or

Health Authority submission timelines.

Manages and facilitates review of CCDSs and regional labeling, as appropriate, via the Label-

ing Team and executive governance committees for PDT BU products.

Prepares final proposed labeling for review by the Labeling Team and approval by the execu-

tive governance committees, as appropriate, prior to internal approval and/or submission to

health authorities.

Manages the preparation of submission-ready labeling components, consults with affiliates on

Health Authority communications regarding labeling.

Ensures internal and external stakeholder awareness of proposed and newly approved labeling changes, as required.

Ensures compliant version control of product labeling and other related documentation within

the Takeda document management systems.

Ensures QC of CCDSs and other labeling documents.

Updates labeling decision records to ensure labeling history is appropriately tracked and ar-

chived.

Ensures Takeda employee awareness of, and adherence to, Takeda Labeling processes via

regulatory training.

Designs and delivers labeling training programs.

Documents labeling tracking information as required in end to end tracking systems to facilitate

overall compliance and oversight of labeling 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 behaviors 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 execu-

tion 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 RnD used data to make deci-

sions 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 in-

tangible 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 de-

gree of complexity

Ability to provide data that will resolve or simplifies complexity between commercial, opera-

tions, 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

labeling 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

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 labeling, specifically, EU and US labeling requirements and

guidance. Combination product/drug-device labeling 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) Labeling

Tracking Systems to support labeling documentation, tracking, and compliance activities.