Associate Project Director, Global Regulatory Affairs & Patient Safety
Ascendis Pharma · Hellerup
Job description
About the role
Ascendis Pharma is seeking an experienced Associate Project Director to lead strategic and operational initiatives within Global Regulatory Affairs & Patient Safety (GRAPS). The role translates GRAPS priorities into integrated plans, ensuring disciplined execution across multiple functions and geographies.
Key responsibilities
- Lead GRAPS projects from initiation to closeout, defining scope, governance, milestones, budgets, risks and measurable outcomes.
- Partner with GRAPS leaders to convert strategic priorities into roadmaps and maintain a consolidated view of the project portfolio.
- Establish and facilitate governance forums, steering committees, stage reviews and prepare executive dashboards and decision materials.
- Coordinate stakeholders across Regulatory Affairs, Patient Safety, Clinical Development, Medical Affairs, Quality, IT, Finance, HR, Legal, Procurement and external partners.
- Drive operational excellence by standardising processes, tools and ways of working while supporting GxP, regulatory and pharmacovigilance requirements.
Required profile
- At least 8 years of experience in pharmaceutical, biotechnology or another highly regulated industry.
- Proven track record leading complex, cross‑functional projects involving senior stakeholders, multiple functions and geographies.
- Strong analytical, structured and detail‑oriented mindset with a patient‑focused, enterprise perspective.
- Excellent stakeholder management, influencing without formal authority and ability to work in a global matrix organization.
Required skills
- Project‑management expertise covering scope, schedule, governance, resources, budgets, risks and benefits realization.
- Working knowledge of drug development and commercialization, especially Regulatory Affairs, Pharmacovigilance or Patient Safety.
- Proficiency with Microsoft 365 and project‑management/reporting tools for executive‑ready dashboards.
- Project‑management certification such as PMP or PRINCE2; Agile or change‑management training is a plus.
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Ascendis Pharma
Hellerup
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