GlaxoSmithKline
Executive Director - Strategic Labelling
GlaxoSmithKline, Cambridge, Massachusetts, us, 02140
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Position Summary We are seeking an experienced and dynamic
Executive Director, Strategic Labelling
to lead global labelling development and governance for GSK's diverse portfolio of medicines and vaccines. This role is pivotal in driving the initiation and development of labelling aligned with Target Medicine Profiles (TMP) and Target Vaccine Profiles (TVP) from early lifecycle stages through to commercialization. You will ensure labelling progresses seamlessly through project milestones and governance processes, while maintaining compliance with external regulations and GSK standards. The role offers an exciting opportunity to engage with senior stakeholders across R&D, Regulatory, Safety, and Commercial functions, fostering collaboration and innovation in labelling standards. The ideal candidate will bring strong leadership skills, deep expertise in regulatory affairs, and a commitment to delivering impactful labelling solutions that support GSK's portfolio and global health initiatives.
Responsibilities
Lead the global labelling process for GSK's development portfolio through early lifecycle stages.
Ensure regulatory requirements related to product information and submission strategies are met, proactively resolving issues across therapy areas.
Provide strategic direction for labelling governance and represent GSK in global labelling committees and industry events.
Advise senior management and regulatory teams on product labelling policies, standards, and compliance.
Manage and motivate the Strategic Labelling team (including team leaders and their teams), fostering collaboration and alignment with GSK's principles.
Represent GSK in industry groups and during internal and external regulatory inspections or audits related to labelling governance and processes.
Why You? This role is hybrid with flexibility to work remotely and on-site as required. We value inclusion and welcome applicants from all backgrounds.
Basic Qualification
Bachelor's degree in Science, Medicine, or Pharmacy
Regulatory experience across all phases of the drug development process in a global pharmaceutical company
Global labelling experience
People management and matrix leadership experience
Preferred Qualification
Advanced degree (MS, PharmD, PhD) in Science, Medicine, or Pharmacy
Regulatory Affairs strategy experience, preferably in a leadership role
Deep understanding of multi-regional external regulatory environments
Proven ability to rapidly assimilate data and resolve complex problems, making recommendations to senior management
Proven ability to lead global teams, resolve complex regulatory and scientific issues, and influence effectively in a matrix environment.
Strong interpersonal, presentation, and communication skills with established internal and external networks.
How to apply If you are ready to lead labelling strategy that helps bring safe and effective medicines to patients worldwide, we want to hear from you. Apply now and tell us how your experience and values align with this role.
Salary and Benefits If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $221,925 to $369,875. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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Position Summary We are seeking an experienced and dynamic
Executive Director, Strategic Labelling
to lead global labelling development and governance for GSK's diverse portfolio of medicines and vaccines. This role is pivotal in driving the initiation and development of labelling aligned with Target Medicine Profiles (TMP) and Target Vaccine Profiles (TVP) from early lifecycle stages through to commercialization. You will ensure labelling progresses seamlessly through project milestones and governance processes, while maintaining compliance with external regulations and GSK standards. The role offers an exciting opportunity to engage with senior stakeholders across R&D, Regulatory, Safety, and Commercial functions, fostering collaboration and innovation in labelling standards. The ideal candidate will bring strong leadership skills, deep expertise in regulatory affairs, and a commitment to delivering impactful labelling solutions that support GSK's portfolio and global health initiatives.
Responsibilities
Lead the global labelling process for GSK's development portfolio through early lifecycle stages.
Ensure regulatory requirements related to product information and submission strategies are met, proactively resolving issues across therapy areas.
Provide strategic direction for labelling governance and represent GSK in global labelling committees and industry events.
Advise senior management and regulatory teams on product labelling policies, standards, and compliance.
Manage and motivate the Strategic Labelling team (including team leaders and their teams), fostering collaboration and alignment with GSK's principles.
Represent GSK in industry groups and during internal and external regulatory inspections or audits related to labelling governance and processes.
Why You? This role is hybrid with flexibility to work remotely and on-site as required. We value inclusion and welcome applicants from all backgrounds.
Basic Qualification
Bachelor's degree in Science, Medicine, or Pharmacy
Regulatory experience across all phases of the drug development process in a global pharmaceutical company
Global labelling experience
People management and matrix leadership experience
Preferred Qualification
Advanced degree (MS, PharmD, PhD) in Science, Medicine, or Pharmacy
Regulatory Affairs strategy experience, preferably in a leadership role
Deep understanding of multi-regional external regulatory environments
Proven ability to rapidly assimilate data and resolve complex problems, making recommendations to senior management
Proven ability to lead global teams, resolve complex regulatory and scientific issues, and influence effectively in a matrix environment.
Strong interpersonal, presentation, and communication skills with established internal and external networks.
How to apply If you are ready to lead labelling strategy that helps bring safe and effective medicines to patients worldwide, we want to hear from you. Apply now and tell us how your experience and values align with this role.
Salary and Benefits If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $221,925 to $369,875. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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