Regulatory Affairs Senior Manager, CMC
Novartis
14 hours ago
Remote friendly (East Hanover, NJ)
United States
Corporate Functions
Responsibilities:
- Lead and implement global CMC regulatory strategies for assigned products and projects.
- Plan, author, review, and coordinate high-quality regulatory submissions.
- Ensure regulatory compliance, technical accuracy, and alignment with global guidelines.
- Identify risks, develop mitigation plans, and communicate key issues to stakeholders.
- Collaborate across cross-functional teams to support product development and lifecycle management.
- Lead interactions with health authorities, including preparation and coordination of submissions and responses.
- Support due diligence activities for business development opportunities.
Qualifications/Requirements:
- 5+ years of experience in regulatory affairs and/or the pharmaceutical industry.
- Understanding of regulatory submission and approval processes.
- Knowledge of chemistry, biotechnology, analytics, or pharmaceutical technology, with ability to evaluate scientific data across disciplines.
- Experience working collaboratively in cross-functional or global teams; ability to manage and prioritize multiple activities.
- Ability to work independently and contribute effectively in team environments.
- Strong planning, organizational, and communication skills.
- Confidence using digital tools and systems relevant to the role.
Benefits (as stated):
- Salary expected to range from $119,700 to $223,300 per year (final determined by skills/experience; reviewed periodically).
- Performance-based cash incentive; eligibility for annual equity awards (depending on level).
- Comprehensive benefits package for US-based eligible employees (health, life and disability, 401(k) with match) and generous time off (vacation, personal days, holidays, and other leaves).
- Lead and implement global CMC regulatory strategies for assigned products and projects.
- Plan, author, review, and coordinate high-quality regulatory submissions.
- Ensure regulatory compliance, technical accuracy, and alignment with global guidelines.
- Identify risks, develop mitigation plans, and communicate key issues to stakeholders.
- Collaborate across cross-functional teams to support product development and lifecycle management.
- Lead interactions with health authorities, including preparation and coordination of submissions and responses.
- Support due diligence activities for business development opportunities.
Qualifications/Requirements:
- 5+ years of experience in regulatory affairs and/or the pharmaceutical industry.
- Understanding of regulatory submission and approval processes.
- Knowledge of chemistry, biotechnology, analytics, or pharmaceutical technology, with ability to evaluate scientific data across disciplines.
- Experience working collaboratively in cross-functional or global teams; ability to manage and prioritize multiple activities.
- Ability to work independently and contribute effectively in team environments.
- Strong planning, organizational, and communication skills.
- Confidence using digital tools and systems relevant to the role.
Benefits (as stated):
- Salary expected to range from $119,700 to $223,300 per year (final determined by skills/experience; reviewed periodically).
- Performance-based cash incentive; eligibility for annual equity awards (depending on level).
- Comprehensive benefits package for US-based eligible employees (health, life and disability, 401(k) with match) and generous time off (vacation, personal days, holidays, and other leaves).