Gnosis is seeking for a Regulatory Affairs Specialist to join its Regulatory team. Our regulatory members are organized in two teams, one focused on customer’s requests and local projects depending on the market needs (Regulatory Hub team) and the other one focused on product development/life cycle management and long-term regulatory projects. (Regulatory Experts team)

This new position will reinforce the Regulatory Hub Team. You will play a crucial role in ensuring the company's products and operations comply with relevant regulatory requirements across different markets.

As our Hub Regulatory affairs Specialist, you will be the primary regulatory point of contact for customers, focusing on the Americas and EMEA regions, with some activities in the APAC region.

On your day to day, you will:

• Respond to customer regulatory inquiries and coordinate regulatory activities for customer projects, ensuring compliance with regulatory requirements and prompt resolution of any issues that arise.
• Collaborate strongly with the sales team, R&D, quality, manufacturing, and other departments to gather necessary information and align on regulatory requirements
• Develop and implement regulatory strategies based on the business needs: Analyse regulations and provide necessary recommendations with risk assessments and estimated timeline & costs
• Establish and maintain effective communication channels with sales or customers, understanding their regulatory needs and requirements, and providing tailored solutions to address their concerns.
• Perform products regulatory assessments aligned with the BU strategy with or without the support of external consultants or lawyers. Challenge the assessment as needed and ensure timely follow-up.
• Present regulatory assessments to relevant stakeholders, communicating key findings and proposed action plans to ensure regulatory compliance while expanding market access.
• Manage regulatory projects: gather and compile the necessary data for registration dossiers in collaboration with relevant departments and oversee the submission while ensuring timely follow-up with regulatory authorities.
• Create internal regulatory memos to enhance regulatory expertise within the department and ensure appropriate archiving for reference and future use.
• Contribute to the development of regulatory strategies and policies, leveraging insights gained from customer interactions and cross-functional collaboration to drive continuous improvement.
• Participate actively in the internal regulatory intelligence & monitor evolvement of global regulatory requirements to assess the impact of changes on the company's products and business.
• Manage the budget of assigned regulatory affairs activities and projects
• Contribute to the development of a regulatory culture across the organization by providing regulatory best practices and conducting regulatory webinars to engage internal stakeholders
• Ensure accurate and up-to-date maintenance of the company's internal regulatory database for assigned ingredients and regions.

Qualifications:

• Master's degree in a scientific / technical field, preferably in pharmacy, food science, relevant life sciences or chemical industry.
• At least 2-4 years of experience in regulatory affairs in the food supplement, pharmaceutical or food industries.

Technical Knowledge:

• Demonstrated knowledge and understanding of the regulatory frameworks applicable to food/food supplements or pharmaceuticals, including FDA, EFSA, TGA, and other global regulatory agencies.
• Proven experience in leading / managing regulatory projects across different markets.
• Regulatory writing & strategy development skills
• Strong understanding of scientific and technical aspects of regulatory files.
• Experience in risk management and risk assessment in a regulatory context.

Skills:

• Fluent in English, both written and verbal, with the ability to communicate effectively with international stakeholders.
• Strong interpersonal and collaboration skills.
• Ability to work effectively with EU/France-based cross-functional teams.
• Excellent written and verbal communication skills with the ability to communicate complex technical information to various stakeholders.
• Critical thinking and problem-solving skills & Scientific rigor, attention to detail and accuracy.