Overview In this role you will support regional regulatory strategies for QOL initiatives, aligning with corporate objectives and regional requirements. You will guide the regulatory team, prepare submissions, and foster relationships with regional authorities. You will stay ahead of regional regulatory trends and contribute to risk mitigation and post-marketing activities. You will collaborate across functions to integrate QOL considerations into development, manufacturing, and commercialization, while reporting to senior leadership and ensuring inspection readiness.
Responsibilities- Support development and execution of regional regulatory strategies for QOL initiatives
- Provide strategic oversight to the regulatory team and ensure alignment with company objectives
- Prepare and submit regulatory documents for QOL initiatives to authorities
- Collaborate with cross-functional teams to integrate QOL into product development, manufacturing and commercialization
- Foster relationships with regional regulatory authorities for communication and negotiations
- Monitor regulatory developments in regions and advise leadership
- Identify and address regulatory risks and opportunities for QOL initiatives
- Guide post-marketing regulatory activities including variations, renewals, labeling updates, and compliance initiatives
- Represent company interests in industry forums, groups, and regulatory meetings
- Coordinate with global regulatory counterparts to align regional strategies with global plans
- Prepare regulatory updates, progress reports, and strategic recommendations for leadership and governance committees
- Assist in documentation for regulatory inspections and inspection readiness
- Participate in facilitating communication and respond to inspection readiness team queries
Key requirements- Bachelor's degree in life sciences or related field
- 5+ years in regulatory affairs in pharma/biotech
- Branded product regulatory affairs experience
- Cross-functional teamwork experience
- Strong knowledge of FDA and ICH guidelines
- Excellent communication and interpersonal skills
- Ability to develop regional regulatory strategies
- Strong organizational skills and attention to detail
- Regulatory submissions and documentation knowledge
- Awareness of regional regulatory developments
- Strong analytical and problem-solving skills
- Ability to work independently and prioritize tasks
- Willingness to travel 10% (domestic and international)
- excellent communication
- interpersonal skills
- cross-functional collaboration
- regional regulatory requirements (FDA, ICH)
- regulatory strategy development
- submissions and documentation processes
