About the Role
Lead the regulatory intelligence and analytics function, collaborating with cross-functional teams to provide insights and support strategic decision-making. Ensure compliance with global regulations and maintain a proactive approach to regulatory changes.
Responsibilities
- Lead the regulatory intelligence and analytics function, providing strategic direction and ensuring alignment with business objectives.
- Develop and implement processes to monitor and analyze regulatory changes and trends.
- Collaborate with cross-functional teams to provide insights and support strategic decision-making.
- Ensure compliance with global regulations and maintain a proactive approach to regulatory changes.
- Manage and mentor a team of regulatory intelligence analysts, fostering a culture of continuous improvement.
- Prepare and present regulatory intelligence reports to senior leadership and stakeholders.
- Identify and mitigate regulatory risks, providing recommendations to minimize potential impacts.
- Conduct regulatory horizon scanning to identify emerging trends and potential impacts on the organization.
- Develop and maintain relationships with key regulatory bodies and industry stakeholders.
- Provide regulatory intelligence support to clinical development, medical affairs, and other relevant functions.
- Contribute to the development and implementation of regulatory strategies and policies.
- Ensure the accuracy and timeliness of regulatory intelligence data and reports.
- Stay up-to-date with regulatory developments and best practices in the industry.
- Collaborate with external consultants and vendors to enhance regulatory intelligence capabilities.
- Participate in regulatory intelligence projects and initiatives, providing expertise and guidance.
- Develop and deliver training and education programs on regulatory intelligence topics.
- Support the development and implementation of regulatory intelligence tools and technologies.
- Ensure the confidentiality and security of regulatory intelligence information.
- Provide regulatory intelligence support to business development and licensing activities.
- Collaborate with legal and compliance teams to ensure regulatory intelligence aligns with organizational policies and procedures.
- Participate in regulatory intelligence conferences and events, representing the organization and staying current with industry trends.
- Provide regulatory intelligence support to crisis management and business continuity planning.
- Develop and implement metrics and KPIs to measure the effectiveness of regulatory intelligence activities.
- Collaborate with IT and data management teams to ensure the integrity and accessibility of regulatory intelligence data.
Nice to Have
- Advanced degree in a relevant field, such as regulatory affairs, life sciences, or a related discipline.
- Certification in regulatory affairs or a related field.
- Experience in the pharmaceutical, biotechnology, or medical device industries.
- Fluency in multiple languages, with a strong understanding of global regulatory environments.
- Experience in conducting regulatory intelligence projects and initiatives in a global context.
- Proficient in regulatory intelligence software and tools, with a strong understanding of data analysis and visualization techniques.
- Experience in developing and implementing regulatory intelligence strategies and policies in a global context.
- Knowledge of regulatory intelligence best practices and industry standards in a global context.
- Experience in conducting regulatory risk assessments and providing recommendations to minimize potential impacts in a global context.
- Proficient in regulatory intelligence databases and software, with a strong understanding of data management principles in a global context.
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work arrangement with flexibility for remote work
Team
Collaborative and dynamic team environment with a focus on continuous improvement and innovation
About the Role
- This role is responsible for leading the regulatory intelligence and analytics function, providing strategic direction and ensuring alignment with business objectives.
- The role involves developing and implementing processes to monitor and analyze regulatory changes and trends, as well as collaborating with cross-functional teams to provide insights and support strategic decision-making.
- The role requires a strong understanding of global regulatory environments and trends, with a focus on key markets.
- The role involves managing and mentoring a team of regulatory intelligence analysts, fostering a culture of continuous improvement and innovation.
- The role requires excellent communication and presentation skills, with the ability to convey complex information to diverse audiences.
What You'll Do
- Lead the regulatory intelligence and analytics function, providing strategic direction and ensuring alignment with business objectives.
- Develop and implement processes to monitor and analyze regulatory changes and trends.
- Collaborate with cross-functional teams to provide insights and support strategic decision-making.
- Ensure compliance with global regulations and maintain a proactive approach to regulatory changes.
- Manage and mentor a team of regulatory intelligence analysts, fostering a culture of continuous improvement and innovation.
What You'll Need
- Proven experience in regulatory intelligence, regulatory affairs, or a related field.
- Strong analytical and problem-solving skills, with the ability to interpret complex regulatory information.
- Excellent communication and presentation skills, with the ability to convey complex information to diverse audiences.
- Proficient in regulatory intelligence tools and technologies, with a strong understanding of data analysis and visualization techniques.
- Experience in managing and mentoring teams, with a focus on developing talent and fostering a culture of continuous improvement.
What We Offer
- Competitive salary and benefits package
- Hybrid work arrangement with flexibility for remote work
- Collaborative and dynamic team environment with a focus on continuous improvement and innovation
- Visa sponsorship is available for eligible candidates
- Opportunities for professional development and growth
How to Apply
- Submit your application through the company's career portal, including your resume and a cover letter outlining your qualifications and experience.
- Include any relevant certifications or additional information that supports your application.
- Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for an interview.
Visa sponsorship is available for eligible candidates
