Regulatory Affairs Regional Associate Director, LACan

Band

Level 5

 

Job Description Summary

The Regulatory Affairs (RA) Regional Associate Director works under limited supervision of the Sub-Region Head or Region Head to provide strategic support and oversight to the regional team, ensuring smooth business operations and effective decision-making. The RA Regional Associate Director acts as a trusted advisor to the Region Head and Sub-Region Heads, and supports resolution of high-priority topics with focus, but not limited to non-priority markets. They also drive activities to enhance regional RA functional excellence, including enhanced working models for RA efficiency, and support cross-functional interfaces with potential impacts on country-level resources.

 

Job Description

#LI-Hybrid

Key Responsibilities:

• Collects information and leads discussions to enable efficient decision-making for the Region RA team and support digesting complex or multi-variable topics and then organizing relevant information and key issues and suggesting for prioritization
• Ensures Regional active oversight and problem solving on emerging high-priority issues, including quality escalations and drug shortage management
• Supports the execution of, or act as a region representative in functional or cross-functional initiatives, particularly those with potential impacts on country-level resources or FTE allocations.
• Supports country RA teams of lower complexity markets, and global RA policy roles to ensure regulatory intelligence and knowledge management is translated into tangible regulatory strategy for Novartis portfolio
• Provides support to local RA teams to guarantee operational and functional excellence of RA country heads/ teams in lower complex markets in collaboration with Region and Sub-region RA heads
• Support International Pipeline Management, Compliance and Ops team to identify opportunities for cross-country and cross-regional cooperation

Essential Requirements:

• Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Advanced degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent is desirable
• Minimum of 6 years in Regulatory, product development; with minimum of 1 year regional or global Regulatory
• Proven track record of Health Authority negotiations
• Ability to develop and communicate strategic vision
• Ability to work in cross-functional environment
• Proven expertise in project management
• Proven track record of early recognition of potential regulatory issues, complex situations, sound risk assessment and overcoming hurdles
• Ability to travel and represent the organization

Desirable Requirements:

• Proven strong matrix leadership skills and organizational awareness
• Proven track record of successful risk assessment

The salary for this position is expected to range between $132,300 and $245,700 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.​

 

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

 

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disa