Overview In this role you drive regional regulatory strategies for QOL initiatives, guiding the regulatory team to align with regional requirements and company objectives. You will oversee regulatory submissions, collaborate with cross-functional partners in development, manufacturing, and commercialization, and maintain relationships with regional authorities. You'll monitor regulatory trends, manage risks, and support post marketing activities and inspections readiness. This is a hands-on, cross-regional role that shapes regulatory decisions and supports global alignment.
Responsibilities- Develop and execute regional regulatory strategies for QOL initiatives under senior leadership guidance
- Provide strategic oversight to the regulatory team to ensure alignment with regional requirements and company goals
- Prepare and submit regulatory documents related to QOL initiatives to authorities
- Collaborate with cross-functional teams to integrate QOL considerations into product development, manufacturing and commercialization
- Foster and manage relationships with regional authorities to facilitate communication and negotiations
- Monitor regulatory developments in specific regions and provide insights to leadership
- Manage regulatory risks and develop mitigation strategies for QOL initiatives
- Support post marketing regulatory activities including variations, renewals, labeling updates, and compliance
- Represent company interests in industry forums, working groups, and regulatory meetings related to QOL initiatives
- Coordinate with global regulatory counterparts to align regional and global regulatory plans
- Prepare regulatory updates, progress reports, and strategic recommendations for governance committees
- Assist in documentation for regulatory inspections and inspection readiness activities
- Support timely and professional responses to questions from the inspection readiness team
Key requirements- Bachelor's degree in life sciences or related field with 5+ years in regulatory affairs in pharma/biotech
- Branded product regulatory affairs experience
- Strong knowledge of FDA regulations and ICH guidelines
- Excellent communication and interpersonal skills
- Ability to develop and execute region-specific regulatory strategies
- Strong organizational skills and attention to detail
- Ability to work independently and manage priorities
- Willingness to travel 10% (domestic and international)
- Proven cross-functional collaboration experience
- Knowledge of regulatory submissions and documentation processes
- Awareness of regional regulatory developments and trends
- Strong analytical and problem-solving skills
- cross-functional collaboration
- effective communication
- attention to detail
- regulatory strategy development
- regulatory submissions and documentation
- inspection readiness
