Regulatory Liaison Manager

Purpose of the Position

In this role, you will have the opportunity to coordinate regulatory activities in the EU, UK, Switzerland, and non-EU SEE countries under the supervision of the (Senior) Principal Scientist of Regulatory Affairs. You will be responsible for implementing strategies for products in development with guidance and independently developing and executing strategies for registered products. Additionally, you will play a crucial role in managing submissions and interactions with the EU regulatory agencies. It will be your responsibility to directly liaise with HQ US-based cross-functional teams, effectively communicating regional requirements and ensuring compliance with all necessary regulations for assigned projects. You will also coordinate or oversee the preparation of regulatory documentation in a timely manner, aligning with corporate objectives. Furthermore, as an integral part of the team, you will serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams.

Primary Activities

• Under supervision from the (Senior) Principal Scientist, coordinate the preparation, review, and submission of regulatory dossiers for new product registrations and post-approval submissions in the EU, UK, Switzerland, and non-EU SEE countries.
• Work with cross-functional project teams to develop and implement regulatory strategies, including scientific advice, pediatric investigational plans, and orphan designation.
• Identify regulatory risks and ensure alignment of regulatory strategies with project teams and business objectives.
• Accountable for interacting with regulatory agencies and Country RA teams to facilitate smooth submission, assessment, and quick approval of CTAs under the EU Clinical Trial Regulation.
• Serve as the primary regulatory representative to regulatory agencies and Country RA teams.
• Act as the Regulatory Affairs representative on assigned non-product related cross-functional teams.
• Develop and implement effective processes to meet business objectives and ensure compliance with regulatory requirements.
• Continuously build and maintain a sound scientific knowledge and expertise in assigned product areas and regulations.

Your Profile

• Master's degree in pharmacy, chemistry, or equivalent, preferably in a science-related field.
• Minimum of 2 years of experience in the pharmaceutical industry is preferred.
• Strong organizational and planning skills, with the ability to manage multiple projects and adapt to changing priorities.
• Knowledge of EU regulations, guidelines, and regulatory processes for product life cycle maintenance.
• Ability to work in a cross-functional and international environment.
• Fluent written and spoken English is required, along with strong interpersonal, oral, and written communication skills.
• Willingness to travel up to 5% for job-related activities.

Key skills/competency

• Regulatory Affairs Management
• EU Regulations
• Regulatory Compliance
• Product Lifecycle
• Regulatory Submissions
• Cross-functional Collaboration
• Project Coordination
• Pharmaceutical Guidelines
• Risk Assessment
• Communication