Regulatory Policy & Intelligence Director

11 Apr, 2019


Regulatory Policy & Intelligence Director

Rockville, MD

Job Description

Facilitate application of regional regulatory requirements and intelligence to provide strategic direction and product advocacy in global development to achieve Regulatory Affairs enterprise objectives and enable regulatory compliance.
• Provide regular communications and briefings to Global and Regional Policy Heads on relevant global regulatory policy issues • Participate in internal product team meetings to provide regulatory policy context for business decisions • Provide strategic regulatory advice to RA colleagues on drug development projects and registration, and marketed products in preparation for HA meetings. • Develop training materials and participate as a facility member on new and emerging regulatory requirements for RA colleagues and other line functions • Analyze impact of important emerging regulatory policies and new requirements on Novartis projects and business. • Prepare and coordinate internal stakeholder feedback on proposed laws, regulations and guidances, to ensure consideration of Novartis positions by trade organizations • Represent Novartis on external committees e.g. trade associations • Collaborate with Novartis Corporate Affairs to shape emerging legislative proposals • Identify and escalate key information as appropriate within RA, Global Drug Development and other internal stakeholders • Coordinate and lead internal cross-functional groups/task forces on implementation of regulatory guidelines in new and emerging areas.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Minimum requirements

Fluency in English as a business language. Additional language is an asset Fluency in English (written and oral) • Minimum 6-8 years of regulatory and drug/biologic development experience, Health Authority experience desirable. • Demonstrable history of success over multiple years in a regulatory or health policy role with a strong understanding of regulatory and legislative environment • Command of the drug development process, pharmaceutical business • Knowledge and experience with local regulatory affairs and regulations • Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams. • Ability to enable teams to think strategically, creatively and proactively • A flexible, positive and creative thinker with the proven ability to develop and implement innovative policy strategies and processes • Good management, interpersonal, communication (both verbal and written), negotiation and problem solving skills.

Learn more here

Job posted: 2019-04-11