Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Drive global regulatory strategy and submissions for late-stage rare disease therapies at Alexion, AstraZeneca Rare Disease. Lead Health Authority interactions and cross-functional regulatory execution.
Responsibilities
- Own and drive regulatory strategy for late-stage or marketed products
- Serve as the Regulatory Lead, leading end-to-end regulatory strategy across the US and/or other key global jurisdictions (EU, UK, Canada)
- Design and implement submission strategies to support product development, registration, and lifecycle management (INDs, CTAs, BLAs/NDAs, Orphan Drug Designation, pediatric plans)
- Lead interactions and meetings with major Health Authorities (FDA, EMA, HC, MHRA), representing Alexion
- Act as a strategic partner to Clinical, Medical Affairs, Commercial, and Global Program Teams, providing regulatory input that shapes development plans and product strategy
- Lead execution of key submissions and oversee regulatory documentation, timelines, and team deliverables
- Collaborate cross-functionally with Regulatory Operations, Labeling, and CMC to ensure alignment and success
- Stay current on emerging regulatory trends, guidances, and policy shifts and advocate for regulatory innovation
- Support enterprise-level regulatory process development, audit readiness, and inspection response
- Provide strategic and tactical mentorship to regulatory colleagues and contribute to team culture
Requirements
- 8+ years of experience in Regulatory Affairs within pharma or biotech, including US regulatory strategy and submissions
- Proven leadership in global regulatory strategy across the drug development lifecycle, from early development through marketing applications and post-market support
- Deep understanding of the drug development process, global regulatory frameworks, and rare disease or specialty drug pathways
- Track record of leading meetings with Health Authorities (FDA, EMA, HC, MHRA) and managing complex regulatory submissions
- Experience designing and implementing submission strategies including INDs, CTAs, BLAs/NDAs, Orphan Drug Designation, and pediatric plans
- Strong working knowledge of GxPs, emerging regulations, and regulatory intelligence tools
- Demonstrated ability to think strategically, manage risk, and make sound regulatory judgments in fast-moving environments
- Exceptional collaboration and communication skills; ability to influence at all levels including senior leadership
Benefits
- short-term incentive bonus opportunity
- eligibility to participate in our equity-based long-term incentive program
- qualified retirement program [401(k) plan]
- paid vacation and holidays
- paid leaves
- health benefits including medical, prescription drug, dental, and vision coverage
- Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours
- Flexible/hybrid work arrangement (on average a minimum of three days per week from the office)
Job title
Job type
Experience level
Salary
Degree requirement
No Education Requirement
Location requirements
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