Senior Manager, Regulatory Affairs Americas

$161,100 - $187,950/Yr

Lonza - Morristown, NJ

Full-time - Senior

Remote - Morristown, NJ

Professional, Scientific, and Technical Services

About the position

The Senior Manager, Regulatory Affairs Americas ensures regulatory compliance for Lonza's healthcare product portfolio within the AMER Regional Business Unit, including capsules, dosage form solutions (DFS), and Health Ingredients (HI). This role provides expertise to the CHI business unit, supports customer service and sales teams, and manages regulatory issues. The Senior Manager also monitors regulatory requirements for the AMER pharma and nutrition portfolios, implements the AMER regulatory strategy, and collaborates with regional colleagues outside the US. Additionally, the role helps foster a regulatory-compliant culture aligned with the overall business strategy.

Responsibilities

• Coordinate development of regulatory intelligence for regional newsletters and global 'Regulatory Information Bulletin' in collaboration with regional RA teams.
• Oversee regional initiatives with local authorities, ensuring alignment and resource prioritization.
• Leverage trade association intelligence for marketing guidance.
• Monitor new regulations, standards, and trends, providing guidance for regulatory responses or product challenges.
• Build and maintain relationships with key regulatory agencies and industry associations.
• Maintain expertise in relevant AMER regulations and collaborate on regional guidance.
• Maintain the Regulatory Risk Register, assess priorities, and create mitigation plans with regional RA teams.
• Coordinate registrations, supporting studies, and manage regulatory or substance issues, working with RA Leadership, Marketing, R&D, and other functions.
• Keep global SOPs updated for regulatory management, in collaboration with regional RA teams.
• Facilitate regulatory impact assessments and clearance for global trade.
• Consolidate regulatory contributions for global reporting with RA/QA teams.
• Contribute to regional regulatory assessments for global innovation projects.
• Track ongoing regional projects, prioritize based on commercial strategy and resources.
• Set regulatory priorities and align with RA leadership to ensure timely project delivery.
• Represent the Americas regulatory position to global product management, ensuring compliance with innovations and marketing.
• Serve as the regulatory representative in the Americas RBU and develop 'customer delight' regulatory tools and support.
• Coordinate customer support for the portfolio and ensure up-to-date content in servicing platforms.
• Address regional resource gaps and collaborate with global RA functions to build a capable workforce.
• Develop and manage the annual CHI AMER regulatory budget, ensuring alignment with operational and capital planning.

Requirements

• Expert knowledge of US nutritional industry regulatory framework (food/dietary ingredient / dietary supplement and feed / feed supplement), applicable to all BU activities (manufacturing/GMPs, registrations, licensing and sales)
• Comprehensive understanding of CHI nutritional product portfolio (origin, manufacturing, composition), efficacy & side effects, including target market and population.
• Strong communication skills (orally and written)
• Strong analytical skills and structured approach to problem solving
• Capability to perform end to end impact assessments taking overall business strategies into account
• Capability to translate complex matter in comprehensive summaries
• People management skills
• Effective time management and prioritization skills

Benefits

• Performance-related bonus
• Medical and dental coverage
• 401k plan
• Life insurance
• Short-term and long-term disability insurance
• Employee assistance program
• Paid time off (PTO)