About this opportunity
ALKU lists this Director of Regulatory Labeling opportunity in san diego, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Director, Regulatory Affairs (Labeling)
*This position can be onsite in Pasadena, CA or San Diego, CA
*
The Positi
onThe Director of Regulatory Affairs is the client’s Labeling lead, who drives cross-functional development and execution of global regulatory labeling strategy. This individual will manage regulatory labeling through all phases of development and post-approval (end-to-end) ensuring that the latest requirements and standards are me
t.The ideal candidate will have experience collaborating with product and clinical development, medical, market access, and commercial stakeholders to generate phase and time-appropriate target product profile and labeling drafts, has successfully negotiated with health authorities, and global regulatory experienc
e.
Responsibilit
iesCollaborate cross-functionally to develop labeling strategy and lead cross-functional Labeling meetin
gs.Manage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet (CCDS)), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requiremen
ts.Maintain expertise regarding key labeling requirements and stay current with labeling guidelines/regulations as they pertain to the development/maintenance of labeling and advise key stakeholders on the application of these labeling principl
es.Research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authoriti
es.Responsible for proofreading and departmental QC work; ensure quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling document
s).Liaise with cross functional members and stakeholders to obtain input pertaining to labeling including resolution of key regulatory issues and labeling change
s .Partner with Clinical Regulatory and cross-functional teams to support labeling supplements and updates, and health authority interactions related to label
ingEnsure the dissemination of approved labeling documents and supporting documentati
on.Maintain controlled records for all labeling changes and communicate labeling updates to stakeholders at the time of implementati
on.Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and experti
se.Participate in any relevant continuous improvement efforts for the end-to-end labeling proce
ss.Monitor global regulatory environment and assess impact of changes on business and product labeling activiti
es.Facilitate policy development and updates with internal stakeholde
rs.
Requirem
entsBachelor’s degree in life sciences, computer science, or related science discip
lineMinimum 8+ in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic ar
eas.Knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labe
lingExperience leading cross-functional meetings and facilitating strategic discussions, such as negotiating with internal stakeholders and regulatory authorities on complex labeling iss
ues.Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deviations and inconsistenc
ies.Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation to
ols)Ability to maintain highest degree of professionalism, integrity and diplo
macy
Pref
erredExperience with regulatory information management systems (e.g., Veeva RIM, Registrati
ons).Knowledgeable in emerging technologies, including AI applications in regulatory operat
ions.Experience supporting global inspection readi
ness.
Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.