Senior Manager, Regulatory Affairs US Lead
About The Position
The Senior Manager, Regulatory Affairs US Lead leads, plans, prepares, and delivers regulatory strategies and activities for assigned products and projects in the United States, supporting global regulatory strategies. The role aims to achieve successful registration and lifecycle management of technologically complex products for people with rare diseases and unmet medical needs. It provides tactical and strategic regulatory leadership and advice across regulatory and cross-functional teams, supporting regional and global business objectives. The role also builds effective communication and constructive working relationships with business partners and regulatory authorities.
Requirements
- At least 3 years of relevant Regulatory experience in the pharmaceutical industry, including experience with US regional regulatory strategies.
- Bachelor’s degree required.
- Experience providing strategic regulatory advice in relevant jurisdictions, such as the US, for global product development through all stages, including pre-approval and marketed assets.
- Ability to lead multiple projects simultaneously in a time-sensitive environment.
- Ability to build relationships within and across teams and collaborate in a global team environment at all organizational levels, including Senior Management.
- Strong interpersonal, written and verbal communication, and presentation skills.
- Consistent track record of exercising sound judgment in risk assessment.
- Familiarity with new and emerging regulations and guidance.
- Understanding of GxPs in relevant areas and the ability to locate and interpret regulatory information.
- Excellent use of Microsoft 365 tools, ideally with strong PowerPoint skills.
- Experience working with a regulatory documentation system such as Veeva.
- Proficiency in English in a corporate setting.
Nice To Haves
- Relevant postgraduate degree, such as an MSc, PharmD, or PhD.
- Additional languages.
Responsibilities
- Develop and implement US regulatory strategies for assigned projects and products, and provide regulatory advice to cross-functional strategies and deliverables in accordance with business objectives.
- Manage and execute US regulatory submissions, including INDs, BLAs/NDAs, orphan drug designation applications, and pediatric submissions, collaborating with Regulatory and cross-functional teams.
- Represent Alexion as a point of contact with the US FDA and other relevant external partners, including planning and managing regulatory authority meetings in alignment with global regulatory and cross-functional strategies.
- Oversee operational activities related to regulatory authorizations in accordance with current internal and external requirements for assigned jurisdictions.
- Support the Global Regulatory Lead in internal governance and advisory bodies and other internal activities, including developing and managing selected Regulatory processes and procedures and supporting inspections and audits.
- Collaborate with Regulatory teams and Enterprise functions, including Commercial and Medical, to provide regulatory input on business-relevant deliverables for assigned projects, products, and jurisdictions.
- Stay current on and apply regulatory requirements and trends in the assigned jurisdiction and focus area, such as clinical development and lifecycle management.
- Demonstrate exemplary behavior, leadership, ethics, and visibility within the Enterprise and with health authorities and external partners.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
