About the Role
This position supports upcoming regulatory submissions and compliance initiatives by providing expert guidance and ensuring alignment with global standards and internal processes.
Responsibilities
- Lead preparation and review of regulatory submissions for multiple markets
- Advise internal teams on compliance requirements for product development
- Monitor evolving global regulatory landscapes and assess impact on operations
- Collaborate with cross-functional departments to align regulatory strategy
- Support lifecycle management of existing products through regulatory updates
- Ensure documentation meets agency expectations and internal quality standards
- Serve as a subject matter expert during audits or agency interactions
- Develop and maintain regulatory intelligence systems
- Guide project teams through regulatory pathways for new product approvals
- Assist in the development of standard operating procedures for compliance
- Represent regulatory interests in internal governance meetings
- Evaluate product labeling and claims for regulatory accuracy
- Coordinate with external partners on joint regulatory initiatives
- Maintain up-to-date knowledge of FDA, EMA, and other international regulations
- Contribute to risk assessments related to regulatory compliance
Nice to Have
- Advanced degree in regulatory science, pharmacology, or related discipline
- Regulatory Affairs Certification (RAC) credential
- Experience in emerging markets regulatory strategy
- Familiarity with digital health or combination products
- Leadership experience in regulatory project teams
- Direct interaction with health authorities
- Experience in agile or fast-paced development environments
- Knowledge of data privacy regulations affecting health products
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model with flexibility based on project needs and location
Team
Collaborative team environment within a specialized regulatory affairs division
Why Join Us?
- Opportunity to shape regulatory strategy for innovative products in development
- Work alongside experienced professionals in a growth-oriented environment
- Access to professional development and industry training resources
About the Team
- Dedicated group of regulatory experts supporting diverse therapeutic areas
- Emphasis on mentorship, knowledge sharing, and continuous improvement
- Global reach with regional regulatory expertise across key markets
May be available for qualified candidates depending on business needs
