Pharmaceutical Regulatory Affairs | CMC Focus | Global Markets
POSITION OVERVIEW
We are seeking a Senior Regulatory Affairs Associate with 4-8 years of experience to join our regulatory team. This role focuses on the preparation, submission, and maintenance of regulatory dossiers for drug products across multiple markets, with emphasis on CMC (Chemistry, Manufacturing, and Controls) aspects for both small molecules and biologics.
The successful candidate will manage pre and post-approval lifecycle activities, handle regulatory submissions, and provide strategic input on regulatory requirements. Experience with EU and US procedures is essential, while knowledge of other global markets is advantageous.
LOCATION
Flexible / Various locations available
KEY RESPONSIBILITIES
Regulatory Submissions and Maintenance
Contribute to the preparation and delivery of regulatory maintenance submissions from global or regional perspectives. With experience, take on increasing responsibility for authoring submission documents.
Prepare and review Marketing Authorization Applications and variations for various medicinal products including orals and parenterals. Manage filings in the EU through different procedures including DCP, MRP, and National Procedures.
Prepare documentation for different types of variation procedures including Super Grouping, Grouping, and Work-sharing for Marketing Authorizations.
Prepare, review, and submit safety variations to Health Authorities. Perform post-approval CMC-related updates as required.
CMC and Technical Oversight
Conduct regulatory review of DMFs, batch records, specifications, and stability data to ensure compliance with regulatory requirements.
Provide regulatory impact assessments for change proposals. Identify required documentation for EU submissions.
Handle CMC-related Health Authority queries and coordinate responses with cross-functional teams.
Strategic and Cross-Functional Activities
Liaise closely with cross-functional team members on aligned product responsibilities. Maintain strong working relationships with Regulatory Affairs colleagues, Quality, Manufacturing, and other departments.
Execute and maintain submission delivery plans and submission content plans. Proactively provide status updates to designated stakeholders.
Maintain good understanding of regulatory framework and regional trends for various application types and procedures across all regions.
Systems and Processes
Work with Regulatory Information Management Systems, specifically Veeva Vault. Ensure accurate and timely documentation of all regulatory activities.
Maintain knowledge of global pharmaceutical legislation and guidance, particularly regulatory CMC aspects in ICH countries.
REQUIREMENTS
Experience
4-8 years of relevant experience in regulatory affairs within the pharmaceutical industry. Experience should include handling pre and post-approval lifecycle management of drug products for both small molecules and biologics across various markets.
Regulatory Knowledge
Working knowledge of EU and US regulatory procedures including post-approval requirements. Good understanding of regulatory framework and regional trends for various application types and procedures. Familiarity with ROW markets regulatory legislations is an added advantage.
Strong understanding of global pharmaceutical legislation and guidance, specifically regulatory CMC aspects in ICH countries.
Technical Expertise
Experience in handling CMC-related Health Authority queries. Ability to review DMFs, batch records, specifications, and stability data for regulatory compliance.
Proficiency in preparing Marketing Authorization Applications and variations for EU through DCP, MRP, and National Procedures. Experience with variation procedures including Super Grouping, Grouping, and Work-sharing.
Systems
Working experience in Regulatory Information Management Systems, preferably Veeva Vault.
Skills and Attributes
Strong communication skills with ability to guide and mentor team members. Ability to work independently and manage multiple priorities. Detail-oriented with strong organizational capabilities. Collaborative mindset with ability to work effectively across functions.
WHAT YOU WILL DO
Submission Preparation and Management
You will prepare and review regulatory submissions for marketing authorizations and variations. You will ensure all documentation meets regulatory requirements and is submitted within established timelines.
Lifecycle Management
You will manage the regulatory lifecycle of assigned products, handling both pre-approval and post-approval activities. You will assess the regulatory impact of changes and prepare appropriate submissions.
Cross-Functional Collaboration
You will work closely with colleagues in Regulatory Affairs, Quality, Manufacturing, and other departments. You will provide regulatory guidance and ensure alignment on product strategies.
Health Authority Interactions
You will prepare responses to Health Authority queries, particularly those related to CMC. You will contribute to successful outcomes in regulatory interactions.
Mentoring and Guidance
With your experience, you will guide and mentor less experienced team members. You will share knowledge and contribute to team development.
REGULATORY KNOWLEDGE AREAS
EU Procedures
DCP (Decentralised Procedure), MRP (Mutual Recognition Procedure), National Procedures, Variation procedures including Super Grouping, Grouping, and Work-sharing
US Procedures
Post-approval requirements, CMC submissions and updates
ICH Guidelines
CMC requirements, Quality guidelines, Stability requirements
Global Markets
Knowledge of ROW markets is advantageous, Regional trends and requirements
WHAT SUCCESS LOOKS LIKE
Regulatory Compliance
Submissions are accurate, complete, and submitted on time. Products remain compliant throughout their lifecycle. Health Authority queries are handled effectively.
Cross-Functional Collaboration
You work effectively with colleagues across departments. Regulatory requirements are clearly communicated and understood. Teams are aligned on submission strategies and timelines.
Team Development
You contribute to the growth and development of team members. Your knowledge and experience benefit the wider regulatory group.
Independent Work
You manage your portfolio with minimal supervision. You proactively identify issues and propose solutions. You take ownership of your responsibilities.
WHY THIS ROLE MATTERS
Regulatory affairs ensures that safe, effective, and high-quality medicines reach patients. Every submission you prepare, every variation you manage, and every Health Authority query you answer contributes to bringing therapies to market and keeping them available for patients who need them.
This role offers the opportunity to work on diverse products across multiple markets, building deep expertise in global regulatory affairs.
QUALIFICATIONS SUMMARY
Experience: 4-8 years in pharmaceutical regulatory affairs
Products: Small molecules and biologics
Markets: EU and US essential; ROW advantageous
Technical: CMC expertise, DMF review, variation management
Systems: Veeva Vault or similar RIMS
Skills: Independent work, cross-functional collaboration, mentoring
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 and cross-functional partners.
Decisions and offers are communicated in a timely manner.
TO APPLY
Please submit your resume highlighting your regulatory affairs experience. Include details of your work with EU and US procedures, CMC submissions, and any experience with biologics or ROW markets. Tell us why you are interested in this Senior Regulatory Affairs Associate role.
Apply for the Senior Regulatory Affairs Associate position.
We are an equal opportunity employer committed to diversity and inclusion in the workplace. We welcome applications from all qualified candidates.
