Global Regulatory Pharma Director

North Search is a leading international talent consultancy partnering with organizations across rapidly changing sectors to deliver outstanding talent and innovative leadership.

We are excited to announce a unique opportunity with one of Europes foremost Mid-Size Pharma groups.

The Global Director of Regulatory Affairs Portfolio and Labeling will be responsible for building

and leading a team of international regulatory professionals to develop and execute regulatory strategies to register and maintain access for multiple late-stage medicinal products API programs and managing labeling and regulatory intelligence at the company.

This role plays a critical part in providing leadership and strategic regulatory oversight for different projects ensuring that the latest regulatory requirements and standards are met in line with business objectives and in coordination with key internal stakeholders at departmental

corporate and local levels. This includes responsibility for the input and implementation of global regulatory strategies ensuring timely preparation review and submission of applications to International regulatory authorities via affiliates and partners. Externally you will interface with national regulators and international organizations regarding registration and labeling strategies providing insights to the organization of evolving regulatory policy and its impact on business. You will sit on the QRP leadership team and represent regulatory on the commercial leadership team. You also have line management people development and performance management responsibilities across a broad geographic area.

Key Roles responsibilities:

Accountable for all activities for marketed products without development activities.

Point person for the Global & Regional management for all regional regulatory-related issues and questions.

Lead and coordinate regulatory activities across the Region working with Distributors and Affiliates to speed up the registration align processes and systems to ensure consistency between RA strategies and business priorities.

Oversee a team of international regulatory leads tasked with the development and implementation of regional regulatory strategies.

Provide regulatory guidance strategic and tactical advice to project teams and management including identifying and assessing regulatory risks managing issues and finding solutions for complex problems.

Ensure the regulatory leads have appropriately defined the international strategy and plan for submissions to regulatory authorities in-depth to ensure successful communication of that strategy to the affiliates and partners for marketed products without development activities.

Serve on the Commercial Leadership Team and the QRPV Leadership Team as the regulatory representative for portfolio and labeling as applicable.

Effectively communicate the specific ex-US considerations for the companys global activities.

Collaborate with regional commercial partners to align on regulatory strategies that are in the best interest of both parties.

Facilitate communication with and provide strategic direction to country affiliates and partner regulatory contacts.

Oversee development and presentation of regulatory strategies for governance milestones.

Support international expansion initiatives providing regulatory guidance for territories of interest.

Evaluate intelligence on regulatory matters that may affect the concerned portfolio and communicate the implications of such intelligence.

Oversee the preparation of meeting requests and briefing documents and the coordination and preparation of teams for health authority meetings.

Conduct diligence activities for potential in-license and acquisition opportunities in scope.

Ensure appropriate regulatory resourcing and budgeting to meet the company objectives.

Manage train and mentor regulatory affairs team.

Your qualifications

Bachelors or Masters degree in Science Regulatory Affairs or a related field.

15 years of progressive regulatory experience in the Life Science Industry (Pharma ethical products).

Previous experience in the preparation and submission of MAAs or major Type II Variations/Line Extensions.

Experience with marketed products and labeling optimization investigational drugs including late-stage development is a plus.

Excellent organisational computer (digital and AI is a plus).

Significant leadership experience in a multinational role.

Proven ability to influence cross-functionally.

Able to work independently and effectively in complex rapidly changing.

Sense of urgency combined with flexibility diplomacy and the ability to manage expectations.

A true passion for science and for making a difference in patients lives.

Ready

North Search and our client are committed to fostering a diverse equitable and inclusive workplace. We encourage applications from professionals of all gender identities backgrounds and abilities. Take your career to the next levelapply or contact us for more information.