We are seeking a highly motivated Regulatory Scientist to provide regulatory expertise in supporting high-quality submissions, approvals, and local labelling for assigned products. In this role, you will collaborate closely with global and regional teams, contribute to regulatory strategy, support interactions with health authorities and ensure compliance with applicable regulations. You will also influence labelling, promotional strategy and registration milestones while driving continuous improvement initiatives across the region.
Key Responsibilities:
Provide region/country input to global and regional regulatory strategies and submission plans.
Support regulatory governance and decision-making in assigned region.
Lead development and approval of content for local regulatory submissions.
Support interactions with regulators and cross-functional teams for approvals and labelling.
Ensure compliance with all applicable regulations and internal quality systems.
Monitor and interpret new guidelines, anticipating impacts on product registration and strategy.
Collaborate with affiliates and stakeholders to align on labelling, promotion and registration needs.
Contribute to continuous improvement initiatives and share regulatory expertise across teams.
Qualifications:
~ PhD preferred in scientific or health sciences discipline (Bachelor’s degree required at minimum).
~1–3 years of relevant experience in regulatory affairs or drug development.
~ Knowledge of local/regional regulatory procedures and the drug development process.
~ Strong written, verbal, and presentation communication skills.
~ Developing negotiation and influence skills.
~ Attention to detail and ability to work independently.
~ Ability to assess and manage risk in a highly regulated environment.
~ Commitment to diversity, equity, and inclusion in team collaboration.
Preferred Experience:
Experience supporting regulatory submissions, labelling and health authority interactions.
Familiarity with promotional strategy review in a regulated environment.
Exposure to cross-functional project management and global regulatory collaboration.