Project Manager (Regulatory)

About the role We are looking for an experienced Regulatory Project Manager to independently manage global submissions, lead cross-functional teams, and support regional regulatory strategies. This role bridges global regulatory direction with local market execution and compliance. Key responsibilities • Independently manages submissions and supports major global regulatory filings. • Leads cross-functional team meetings alongside regulatory leads. • Develops, maintains, and tracks submission timelines; identifies critical paths and risks. • Plans and facilitates kick-off and ongoing project meetings including agenda, coordination, and presentations. • Documents meeting minutes, decisions, risks, and action items. • Maintains project plans, dashboards, and collaborative workspaces. • Supports regulatory activities related to contract manufacturing and product transitions, including partner coordination and compliance oversight. • Leads scenario planning and risk mitigation activities. • Tracks content plans with functional teams to ensure timely delivery. • Manages rapid response processes for health authority queries. • Supports advisory committee and health authority meeting preparations. • Coordinates authoring, review, and approval of regulatory documents. • Leads lessons-learned activities and maintains associated logs. • Acts as subject matter expert for local and regional regulatory requirements. • Supports localization of regulatory strategies and submissions per regional authority requirements. • Ensures compliance with country-specific regulations, formats, and timelines. • Provides translation support or review of submission documents in the local language, as needed. Skills & qualifications • Bachelor's or Master's in Pharma, Medical, or a related scientific discipline • 8–10 years overall experience, with at least 2 years in project management; regulatory project management experience is a plus. • Strong knowledge of regional regulatory frameworks, submission processes, and compliance requirements. • Ability to bridge global regulatory strategies with local execution needs. • Experience with project management tools (e.g., MS Project or equivalent). • Strong conceptual and analytical thinking skills. • Excellent interpersonal and business collaboration skills. • Intermediate proficiency in MS Office (Word, Excel, Outlook). • Ability to multitask and prioritize in a fast-paced environment. • Fluency in local language (written and verbal) plus English proficiency.