- Company: Kyowa Kirin North America
- Location: Princeton, Mercer County
- Full Time
- Princeton, Mercer County
- Apply on company site
Kyowa Kirin North America at a glance
kyowakirinnorthamerica.comSEC filings mentioning "Kyowa Kirin North America": 7 — search EDGAR
Join Kyowa Kirin North America as Senior Director, GRA Development & Product Strategy Team Lead (Bone & Mineral). This leadership role in Princeton, Mercer County, offers the opportunity to shape regulatory strategy and drive product development in a high-impact therapeutic area at a rapidly expanding biotechnology organization committed to bringing transformative medicines to patients in areas of unmet medical need.
About the Role
As Senior Director leading our Bone & Mineral regulatory and product strategy function, you will oversee the end-to-end development and commercialization strategy for our bone and mineral disease portfolio. This role combines deep regulatory expertise with strategic product planning, requiring you to set the vision and direction for a growing team while collaborating across research, clinical, commercial, and leadership functions to bring novel therapies from discovery through market approval.
What You'll Do
- Build and mentor a high-performing regulatory and product strategy team, fostering a culture of scientific rigor and innovation
- Define and execute comprehensive regulatory strategies aligned with corporate objectives and market opportunities in bone and mineral therapeutics
- Lead cross-functional initiatives that integrate regulatory requirements, clinical efficacy data, and commercial insights into product development plans
- Serve as internal and external regulatory authority, representing the company to regulatory agencies, investigators, and key stakeholders
- Evaluate competitive landscape and market trends to inform product positioning, lifecycle management, and strategic investment decisions
- Drive compliance with applicable regulations and company policies across all regulatory functions
What We're Looking For
- Master's degree in pharmacy, chemistry, life sciences, or related field; PharmD or equivalent preferred
- 10+ years of progressive regulatory, product development, or strategic planning experience in pharmaceutical or biotechnology
- Proven leadership success managing and developing teams in a complex, matrix environment
- Deep knowledge of FDA regulatory pathways, including IND, NDA, and BLA processes
- Strong scientific foundation and demonstrated ability to translate data into strategic recommendations
- Excellent communication skills and comfort building relationships across organizational levels and external partners
About Kyowa Kirin North America
Kyowa Kirin is a forward-thinking global specialty pharmaceutical company leveraging advanced biotechnology to discover and develop novel therapies in bone and mineral disease, intractable hematologic disorders, hematology oncology, and rare disease. We are driven by a mission to translate science into patient smiles by addressing conditions where treatment options remain inadequate.
How to Apply
To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.
To apply for this job please visit www.adzuna.com.
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Working in Princeton, Mercer County
Weather right now in Princeton, Mercer County: checking… · Local time: · Air quality: · Daylight: · UV index: · Wind:
New Jersey is a state located in both the Mid-Atlantic and Northeastern regions of the United States. Located at the geographic hub of the heavily urbanized Northeast megalopolis, it is bordered to the northwest, north, and northeast by New York State; on its east, southeast, and south by the Atlantic Ocean; on its west by the Delaware River and Pennsylvania; and on its southwest by Delaware Bay a
Nearby history: President's House, listed 1971 (77m away) — via National Register of Historic Places
Typical climate: average high 64°F / low 43°F year-round (summers around 84°F, winters around 24°F) — via NOAA 1991-2020 Normals
- Elevation 69m (226 ft)
Source: Wikipedia (state)
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