Regulatory Affairs Manager - Emerging Markets

Job Description:

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