SoTalent
Senior Manager, Global Regulatory Labeling Strategy
Location: Remote About the Role
We are seeking a Senior Manager, Global Regulatory Labeling Strategy to oversee the development and implementation of labeling content and strategy for assigned pharmaceutical products. This role involves managing cross‑functional labeling teams, ensuring compliance with regulatory requirements, and supporting high‑complexity product labeling. Key Responsibilities
Lead cross‑functional labeling teams to develop and align labeling strategies. Oversee the approval process for labeling content across internal stakeholders. Collaborate with senior management to ensure compliance with global regulatory requirements. Labeling Document Development & Compliance
Author and update key regulatory labeling documents (e.g., CCDS, USPI, EU SmPC). Ensure timely implementation of new scientific, safety, and clinical data into labeling. Support health authority interactions and negotiations on labeling content. Manage local labeling exceptions and ensure alignment with global standards. Partner with internal teams (clinical, medical affairs, safety, commercial) to ensure clear labeling communication. Oversee external vendors supporting labeling activities. Regulatory Research & Process Improvement
Analyze competitor labeling, regulatory trends, and precedents to maintain competitive labeling. Participate in regulatory team meetings and support health authority inspections. Qualifications
Education:
Bachelor’s degree required (advanced degree preferred: MSc, PhD, or PharmD). Experience:
6+ years in the pharmaceutical industry, with at least 4 years in regulatory labeling or related regulatory roles. Strong knowledge of
US and EU regulatory requirements
for product labeling. Ability to develop labeling strategies and co‑author key regulatory documents. Experience with
global regulatory processes
and
cross‑functional collaboration . Competitive salary:
$149,100 – $234,300
(based on location and experience). Comprehensive benefits, including health coverage, retirement plans, and professional development opportunities. This is a remote position and offers the opportunity to work in a dynamic, collaborative environment shaping regulatory labeling strategies for global markets.
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Location: Remote About the Role
We are seeking a Senior Manager, Global Regulatory Labeling Strategy to oversee the development and implementation of labeling content and strategy for assigned pharmaceutical products. This role involves managing cross‑functional labeling teams, ensuring compliance with regulatory requirements, and supporting high‑complexity product labeling. Key Responsibilities
Lead cross‑functional labeling teams to develop and align labeling strategies. Oversee the approval process for labeling content across internal stakeholders. Collaborate with senior management to ensure compliance with global regulatory requirements. Labeling Document Development & Compliance
Author and update key regulatory labeling documents (e.g., CCDS, USPI, EU SmPC). Ensure timely implementation of new scientific, safety, and clinical data into labeling. Support health authority interactions and negotiations on labeling content. Manage local labeling exceptions and ensure alignment with global standards. Partner with internal teams (clinical, medical affairs, safety, commercial) to ensure clear labeling communication. Oversee external vendors supporting labeling activities. Regulatory Research & Process Improvement
Analyze competitor labeling, regulatory trends, and precedents to maintain competitive labeling. Participate in regulatory team meetings and support health authority inspections. Qualifications
Education:
Bachelor’s degree required (advanced degree preferred: MSc, PhD, or PharmD). Experience:
6+ years in the pharmaceutical industry, with at least 4 years in regulatory labeling or related regulatory roles. Strong knowledge of
US and EU regulatory requirements
for product labeling. Ability to develop labeling strategies and co‑author key regulatory documents. Experience with
global regulatory processes
and
cross‑functional collaboration . Competitive salary:
$149,100 – $234,300
(based on location and experience). Comprehensive benefits, including health coverage, retirement plans, and professional development opportunities. This is a remote position and offers the opportunity to work in a dynamic, collaborative environment shaping regulatory labeling strategies for global markets.
#J-18808-Ljbffr