JOB DESCRIPTION:

Regulatory Affairs – Senior Role Summary

1. Product Registrations & Submissions

• Provide high‑level 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 cross‑functional 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 well‑positioned company messaging.

2. Cross‑Functional Leadership

• Represent Regulatory Affairs in senior internal forums, articulating clear regulatory positions and influencing decision‑making 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 decision‑making.

3. Life‑Cycle 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 stakeholders—including Commercial, Quality, Manufacturing, Development, and Business Development—on 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 in‑licensing evaluations and due diligence.

5. Continuous Improvement & Operational Excellence

• Identify opportunities to streamline regulatory processes, enhance operational efficiency, and strengthen cross‑functional 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 in‑licensing opportunities, independently evaluating regulatory risks, feasibility, and integration pathways.

Core Responsibilities

• Provide strategic regulatory direction for assigned projects, including complex or novel issues.
• Lead cross‑functional inputs to create strong regional regulatory plans.
• Prepare and oversee high‑quality 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 high‑quality completion of all assigned regulatory activities.
• No direct budget responsibility; however, expected to identify cost‑saving 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

• Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or related scientific discipline.
• Advanced degree (Master’s or equivalent) strongly preferred.

The base pay for this position is

N/A

In 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