[Hiring] Associate Director, Global Regulatory Affairs Labeling @Daiichi Sankyo, Inc.
Mar 28, 2025 - Daiichi Sankyo, Inc. is hiring a remote Associate Director, Global Regulatory Affairs Labeling. 💸 Salary: unspecified. 📍Location: USA.
Role Description
This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing projects and those involving 3rd party development.
- Partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products.
- Drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products.
- Ensures that draft labeling complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations.
- Interacts across the RA function globally and interacts across functional as well as regional areas.
- Works with ambiguity and complex problems, focusing on strategic and operational decisions.
Responsibilities
- Acts as point of contact for cross-functional teams on global labeling issues.
- May assist another Global Labeling Lead by managing labeling development or approval for either the US or EU based on timelines or resources.
- Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides, EU SmPC, PIL, CCDS).
- Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment.
- Strategizes and plans for FDA meetings as needed.
- Manages updates to Core Data Sheets for assigned products.
- Manages US/EU and local country labeling deviations from CCDS; ensures implementation of CCDS/labeling agreements with licensing partners.
- Prepares documents for review by labeling teams and leads review processes ensuring appropriate governance for US, EU and Company Core documents.
- Researches applicable Health Authority labeling regulations for products and filings.
- Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both content and format.
- Follows internal processes for record keeping and tracking of labeling milestones.
- Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.
- Reinforces labeling best practices at cross-functional meetings.
- Assists in the development of Standard Operating Procedures (SOPs) and process improvements.
- Builds cross-functional and cross-regional relationships.
Qualifications
- Bachelor's Degree preferably in a scientific discipline required; advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred.
- 7 or More Years pharmaceutical industry experience required.
- 4 or More Years of direct regulatory affairs experience, including US labeling experience required.
- Experience with ex-US labeling (outside the US) preferred.
- Ability to travel up to 10%.
Company Description
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
|
Salary
💸
unspecified
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 28, 2025
|
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
