Director, Global Labeling - Regulatory Affairs

Merck Group • $182K — $273K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in science or health-related discipline
  • 8+ years of pharmaceutical industry experience, including 5+ years in Regulatory Affairs Labeling
  • Deep knowledge of US/EU labeling requirements
  • Experience managing teams or personnel in labeling

Responsibilities

  • Lead development and approval of CCDSs and labeling documents with cross-functional teams.
  • Ensure scientific accuracy and compliance of all labeling for healthcare professionals and patients.
  • Provide tactical guidance on labeling processes and regulatory requirements.
  • Disseminate labeling for US/EU implementation and support local regulatory affairs.
  • Support regulatory labeling strategy and development for investigational products.
  • Maintain expertise in global labeling requirements and updated regulations.
  • Participate in agency negotiations to achieve product approvals.

Benefits

  • Hybrid work classification requiring three days in-office per week.
  • Opportunities for professional development and growth within the organization.
  • Collaborative and supportive team environment that fosters inclusivity.
  • Access to leadership principles designed to empower employees.
  • Contribution to meaningful projects that impact healthcare and patient outcomes.
Full Job Description
Work Location: Billerica, Massachusetts
Shift: No
Department: HC-RD-RRF Regulatory Affairs for Advertising Promotion
Recruiter: Molly Scheu

Role-Level: 4

This information is for internals only. Please do not share outside of the organization.

Your Role:

The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. In some instances, the Director of GL may also take on the role of Team Lead for a therapeutic area (TA), overseeing Labeling Project Leads (LPLs) working on products within that TA and fostering strong collaborations with TA leadership. Additionally, the Director of GL assists the Head of Labeling and Advertising and Promotion in preparing for and facilitating interactions with the Labeling Decision Board (LDB), and also driving forward global labeling initiatives.

Location Classification - Hybrid:

This role will be required to work onsite 3 days a week (Tuesday - Thursday) or more depending on business needs. #LI-Hybrid

Key Accountabilities:
  • Lead the development, review, approval, and implementation process for CCDSs, USPIs, EU SmPCs and labeling documents with cross-functional labeling teams. Prepare for senior management (LDB) review and approval.
  • Ensure all labeling is scientifically accurate and meets the needs of healthcare professionals and patients.
  • Provide tactical guidance to labeling teams regarding the labeling process, and regulatory requirements including application to product labeling content.
  • Disseminate labeling for implementation in the US/EU and support country regulatory affairs in implementation changes locally.
  • Support products in development by providing input into investigational brochures, development safety update reports and integrated evidence planning. In some cases, develop regulatory labeling strategy and content for products in development (i.e., target product label) with subject matter experts.
  • Maintain expertise regarding key labeling requirements worldwide and stay updated with FDA/EMA labeling guidelines and regulations.
  • Participate in labeling negotiations with agencies resulting in product approvals or labeling updates.
  • In collaboration with department head, develop and periodically review labeling policies and standards. Provide guidance, and in some cases, drive process improvement initiatives.
  • Support audits and CAPA resolutions.
  • Represent labeling on cross-functional leadership programs and advisory boards.

Minimum Qualifications:
  • Bachelor's degree in science or health-related discipline
  • 8+ years of relevant pharmaceutical industry experience with 5+ years of relevant Regulatory Affairs Labeling experience
  • Deep knowledge and application of labeling requirements in the US/EU
  • Experience managing labeling personnel and/or teams

Preferred Qualifications:
  • Advanced degree (PhD, MD, MS, PharmD, MBA)
  • Advanced proficiency with MS Office (Word, Excel, PowerPoint, Project), SharePoint and regulatory systems (e.g., EDMS)
  • Meticulous in reviewing regulatory documents for accuracy, consistency, and compliance
  • Excellent written and oral communication skills
  • Knowledge and application of labeling requirements in global countries including Japan and China
  • Knowledge of global drug-development and life-cycle management regulations

SpringWorks Leadership Principles:
  • Change Steward - Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
  • Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
  • Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
  • Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment

Compensation & Benefits:

The expected salary range for this position is $182,100 - 273,100. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

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Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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