Regulatory Affairs Manager

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.