Global Regulatory Manager/Lead

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The Global Regulatory Lead, reporting to the Head General Medicines Global Regulatory Unit, will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy of the General Medicines Business Unit. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities. Represents the company with regulatory authorities, contractors and corporate partners. Provides regulatory support for various departments, projects, and teams/committees.

The GRL is accountable for:

• Full oversight and understanding of the product and the company strategy around the program /project

• A sound global regulatory science strategy

• Well functioning Product Regulatory Teams

• Delivering regulatory milestones

• Submission content and quality

• Successful and timely approvals

• Cost-efficient and compliant regulatory life-cycle management

• Sharing product knowledge with all relevant stakeholders

Duties and Responsibilities

• Responsible for directing global regulatory strategies for assigned projects and programs supporting the General Medicines Business Unit.

• Direct global regulatory strategies.

• Direct global life cycle management of products.

• Support change management activities in the post-approval stage.

• Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.

• Provide regulatory guidance to company personnel throughout the research and development process. Represent regulatory science in the core teams.

• Set strategic direction and leads global regulatory submission process with the Product Regulatory Teams, including marketing applications and core briefing packages.

• Direct the organization and preparation of clear and effective submissions.

• Prepare and deliver effective presentations for external and internal audience.

• Monitor and analyze appropriate regulatory agency activities in areas of interest to Gedeon Richter. Assess impact on programs.

• Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.

• Provide leadership on project teams and subcommittees in all areas of regulatory science and product development.

• Provide regulatory assessment during due diligence of potential in-license projects and support business development decisions

• Provide input to the Leadership Team.

• Maintain a global view as part of the whole regulatory team.

Qualifications

• Degree in Life Science or related discipline required. Higher degree preferred (PharmD, MSc, PhD).

• Relevant experience in regulatory science across various regions and regulatory activities (scientific advice, CTA submissions, new submissions, variations, renewals)

• Experience working on products in development relating to CMC, pre-clinical and clinical regulatory aspects of the project.

• Expert knowledge with respect to the global regulatory landscapes

• Experience in interpretation of regulations, guidelines, policy statements, etc.

• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.

• Foster effective, positive interactions with regulatory agencies, and corporate partners.

• Ability to lead and influence project teams, committees, etc. to attain group goals.

• Demonstrate excellent leadership, project management and communication skills.

• Ability to represent the department in project teams, committees and external meetings.

• Demonstrate strong organizational skills, including the ability to prioritize personal workload.

• Ethical, scientific and intellectual integrity

• Excellent verbal and written communication and presentation skills in English.

• The position is fixed-term (maternity leave)

We offer

• Great opportunity for professional development in an innovation driven department
• Great reputation at a well established pharmaceutical firm
• Stability and a trustworthy workplace
• Work in multidisciplinary teams
• Training and development opportunities
• Medical services and life insurance
• Various sport and health opportunities
• Excellent work life balance