Regulatory Affairs Manager Emerging Markets
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Job Location:
Weesp - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Regulatory Affairs Senior Role Summary
1. Product Registrations & Submissions
- Provide highlevel regulatory leadership for global development programs and commercial products across Emerging Markets (defined as all regions except Switzerland the United States Europe Canada and Australia).
- Define drive and optimize global regulatory strategies ensuring full alignment with crossfunctional stakeholders.
- Determine data requirements evaluate scientific evidence against regulatory standards and ensure robust dossier quality.
- Lead the preparation review and approval of complex registration packages and responses to agency inquiries.
- Maintain complete oversight of filings approvals and regulatory documentation throughout the product life cycle.
- Develop strategy and briefing materials for Health Authority interactions ensuring consistent and wellpositioned company messaging.
2. CrossFunctional Leadership
- Represent Regulatory Affairs in senior internal forums articulating clear regulatory positions and influencing decisionmaking across Development Manufacturing Quality and Commercial functions.
- Monitor program execution against strategic plans and timelines identifying risks and enabling proactive mitigation.
- Provide authoritative regulatory insight to support program progression and operational decisionmaking.
3. LifeCycle Compliance
- Evaluate and approve manufacturing and technical changes with regulatory impact ensuring timely updates to global submissions.
- Ensure investigational submissions remain current throughout all phases of development.
- Continuously monitor global regulatory legislation and assess implications for regional business operations and compliance.
- Oversee ongoing regulatory compliance of marketed products across their life cycle.
4. Regulatory Strategy & Business Partnership
- Advise senior stakeholdersincluding Commercial Quality Manufacturing Development and Business Developmenton regulatory requirements and strategic risks.
- Define global and regional regulatory pathways for new product registrations and key lifecycle submissions.
- Provide expert regulatory assessment and strategic guidance during inlicensing evaluations and due diligence.
5. Continuous Improvement & Operational Excellence
- Identify opportunities to streamline regulatory processes enhance operational efficiency and strengthen crossfunctional execution.
- Drive implementation of improved practices that elevate regulatory quality and accelerate timelines.
6. Health Authority Engagement
- Participate in Health Authority meetings representing company regulatory strategy with clarity confidence and scientific rigor.
7. Licensing Responsibilities
- Serve as the primary RA representative for inlicensing opportunities independently evaluating regulatory risks feasibility and integration pathways.
Core Responsibilities
- Provide strategic regulatory direction for assigned projects including complex or novel issues.
- Lead crossfunctional inputs to create strong regional regulatory plans.
- Prepare and oversee highquality submissions ensuring scientific consistency and alignment with company positions.
- Track and report program status escalating issues and recommending solutions where needed.
- Deliver clear persuasive written and verbal communication to internal teams and leadership.
- Maintain expert knowledge of evolving regulatory guidelines and translate regulatory intelligence into actionable strategy.
- Ensure accuracy compliance and scientific integrity of all regulatory deliverables.
Position Scope & Impact
- Operates autonomously with minimal supervision managing significant regulatory responsibilities across multiple functions and geographies.
- Partners closely with EPD RA Affiliate RA teams and regional stakeholders in Commercial QA Operations and Development.
- Accountable for timely and highquality completion of all assigned regulatory activities.
- No direct budget responsibility; however expected to identify costsaving opportunities and ensure efficient resource use.
- Anticipates regulatory risks proactively resolves issues and incorporates learnings to strengthen future regulatory strategies.
- Ensures consistent interpretation and application of regulatory policies across project teams.
Minimum Qualifications
- Bachelors degree in Pharmacy Biology Chemistry Pharmacology or related scientific discipline.
- Advanced degree (Masters or equivalent) strongly preferred.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
Netherlands > Weesp : WHS 02
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
