POSITION OVERVIEW
We are seeking a Senior Regulatory Affairs professional with 11+ years of experience to lead lifecycle management activities for approved and marketed drug products. This role focuses on small molecules, biologicals, vaccines, and monoclonal antibodies across US and EU markets, with exposure to ROW markets as needed.
The successful candidate will lead regulatory maintenance submissions, author CMC components for variations and renewals, and provide strategic guidance on post-approval changes. This is a senior individual contributor role requiring deep regulatory expertise, strong authoring skills, and the ability to work independently while guiding team members.
LOCATION
Remote / Flexible
KEY RESPONSIBILITIES
Lifecycle Management Leadership
Lead and contribute to the planning, preparation, authoring, and delivery of regulatory maintenance submissions from global and regional perspectives. Manage post-approval CMC and labeling updates across US, EU, and ROW markets.
Submission Authoring and Review
Author and review CMC components for Marketing Authorization Applications and variations for various medicinal products including orals and parenterals. Prepare submissions for EU through DCP, MRP, and National Procedures. Author CMC components for annual reports, variations, and renewals in EU (Type IA/IB/II/IAIN), US, and ROW markets.
Regulatory Gap Analysis
Prepare and review regulatory gap analysis and strategy documents with remediation plans for identified gaps. Support submissions including IND, IMPD, DMF, BLA, NDA, and MAA applications.
Health Authority Interactions
Handle CMC-related health authority queries and author responses to HA requests. Manage communications with regulators on post-approval matters.
Change Control Evaluation
Evaluate change controls and deviations, identifying required documentation and submission strategy for EU, US, and other markets. Determine regulatory impact of proposed changes and plan appropriate submissions.
Labeling Management
Author drug product label content for EU, Canada, AU/NZ, and US markets based on Company Core Data Sheet, PRAC, and CMDH recommendations. Apply knowledge of EU Guidelines for QRD and Excipients. Manage artwork for countries with English-language labels.
Stakeholder Coordination
Coordinate with internal and external stakeholders to obtain documentation required for submissions. Identify quality and timeliness issues with source documents early and address proactively.
Regulatory Intelligence
Develop and maintain up-to-date knowledge of regulatory guideline updates. Apply understanding of regulatory requirements and assess their impact on submissions.
Systems and Processes
Work with Regulatory Information Management Systems, preferably Veeva Vault. Ensure accurate documentation and tracking of all regulatory activities.
Mentoring and Guidance
Provide guidance and mentorship to team members. Share knowledge and contribute to team development.
Safety Variations
Review and submit safety variations to Health Authorities. Perform post-approval CMC and labeling updates as required.
REQUIRED EXPERIENCE AND KNOWLEDGE
Experience
11+ years of relevant experience in regulatory affairs within the pharmaceutical or biotechnology industry.
Demonstrated experience in lifecycle management of approved and marketed drug products including small molecules, biologicals, vaccines, and monoclonal antibodies across US and EU markets.
Regulatory Knowledge
Working knowledge of EU and US regulatory procedures including post-approval requirements. Understanding of regulatory framework and regional trends for various application types and procedures. Knowledge of ROW markets regulatory legislations is an added advantage.
Submission Expertise
Experience with IND, IMPD, DMF, BLA, NDA, and MAA submissions. Proficiency in preparing and reviewing CMC components for Marketing Authorization Applications and variations. Experience with EU procedures including DCP, MRP, and National Procedures.
Technical Skills
Strong authoring and review skills for regulatory documents. Experience handling CMC-related health authority queries and authoring responses. Ability to evaluate change controls and determine regulatory impact.
Labeling Knowledge
Experience authoring drug product labels based on CCDS, PRAC, and CMDH recommendations. Familiarity with EU Guidelines for QRD and Excipients. Experience with artwork management for English-language markets.
Systems
Working experience in Regulatory Information Management Systems, preferably Veeva Vault.
Personal Attributes
Ability to work independently with minimal supervision. Strong communication skills with ability to guide and mentor team members. Proactive approach to identifying and resolving issues. Attention to detail and commitment to quality.
REGULATORY KNOWLEDGE AREAS
US Market
Post-approval requirements, CMC submissions, annual reports, variations, labeling updates
EU Market
DCP, MRP, National Procedures, Type IA/IB/II/IAIN variations, renewals, QRD guidelines, labeling
ROW Markets
Canada, Australia, New Zealand labeling requirements
Submission Types
IND, IMPD, DMF, BLA, NDA, MAA
Technical Areas
CMC, change control evaluation, gap analysis, remediation planning, health authority responses
Systems
Veeva Vault RIMS
WHAT YOU WILL DO
Lead Lifecycle Management Activities
You will lead regulatory activities for marketed products across US and EU markets. You will plan and execute post-approval submissions, ensuring continued compliance and market access.
Author Critical Regulatory Documents
You will author and review CMC components for variations, renewals, annual reports, and labeling updates. Your documents will be accurate, complete, and submission-ready.
Provide Strategic Guidance
You will evaluate change controls and determine regulatory impact. You will develop submission strategies that meet business objectives while maintaining compliance.
Coordinate with Stakeholders
You will work with internal and external stakeholders to gather required documentation. You will identify issues early and ensure source documents meet quality standards.
Stay Current with Regulations
You will monitor regulatory guideline updates and assess their impact on submissions. You will apply current requirements to all regulatory activities.
Mentor Team Members
You will guide and mentor less experienced team members. You will share knowledge and contribute to team development.
WHAT SUCCESS LOOKS LIKE
Regulatory Compliance
All post-approval submissions are accurate, complete, and submitted on time. Products remain compliant throughout their lifecycle. Health Authority queries are handled effectively and promptly.
Strategic Impact
Your evaluation of change controls and development of submission strategies supports business objectives while maintaining regulatory compliance.
Quality Documents
Your authored documents are clear, accurate, and require minimal revision. Reviewers trust your work.
Stakeholder Collaboration
You work effectively with stakeholders across functions. Documents are obtained on time and issues are identified early.
Team Contribution
You actively contribute to team development through mentoring and knowledge sharing. Your experience benefits the wider regulatory group.
Independent Work
You manage your portfolio with minimal supervision. You proactively identify issues and propose solutions.
WHY THIS ROLE MATTERS
Lifecycle management ensures that approved medicines remain available to patients, compliant with regulations, and aligned with current scientific knowledge. Every variation, every renewal, every labeling update maintains the ongoing compliance and market access of products that patients depend on.
This senior role offers the opportunity to lead critical regulatory activities for a diverse portfolio of products across major global markets. Your expertise will directly impact the continued availability of medicines for patients worldwide.
QUALIFICATIONS SUMMARY
Experience: 11+ years in pharmaceutical or biotechnology regulatory affairs
Products: Small molecules, biologicals, vaccines, monoclonal antibodies
Markets: US and EU essential; ROW (Canada, AU/NZ) advantageous
Technical: CMC, change control, gap analysis, labeling, health authority responses
Submissions: IND, IMPD, DMF, BLA, NDA, MAA, variations, renewals, annual reports
Systems: Veeva Vault RIMS
Skills: Authoring, review, strategic guidance, mentoring, independent work
APPLICATION PROCESS
Submit your application through the careers portal.
The hiring team reviews all submissions.
Qualified candidates are contacted for an initial conversation.
Interviews are conducted with regulatory leadership.
Decisions and offers are communicated in a timely manner.
TO APPLY
Please submit your resume highlighting your regulatory affairs experience with lifecycle management of marketed products. Include details of your work with US and EU markets, CMC submissions, change control evaluation, and labeling. Tell us why you are interested in this senior regulatory role.
Apply for the Senior Regulatory Affairs Lead – Lifecycle Management position.
We are an equal opportunity employer committed to diversity and inclusion in the workplace. We welcome applications from all qualified candidates. #LI-REMOTE
