Regulatory Affairs Manager (f/m/d)

at  ColgatePalmolive

WHO WE ARE

Colgate-Palmolive Company is a caring, innovative growth company that is reimagining a healthier future for all people, their pets and our planet. Focused on Oral Care, Personal Care, Home Care and Pet Nutrition, we sell our products in more than 200 countries and territories under brands such as Colgate, Palmolive, elmex, hello, meridol, Sorriso, Tom’s of Maine, EltaMD, Filorga, Irish Spring, PCA SKIN, Protex, Sanex, Softsoap, Speed Stick, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Pet Nutrition.
We are recognized for our leadership and innovation in promoting sustainability and community wellbeing, including our achievements in decreasing plastic waste and promoting recyclability, saving water, conserving natural resources and improving children’s oral health.
If you want to work for a company that lives by their values, then give your career a reason to smile and join our global team!

REQUIREMENTS:

• Relevant Master degree in Pharmacy, Biology, Chemistry or equivalent
• Minimum 3-5 years of Regulatory Affairs experience in an international environment, FMCG preferred, in the field of Medicinal Products.
• Fluency in English and German
• Good analytical skills and technical/ scientific competence
• Strong organizational skills
• Attention to details and ability to appropriately assess the regulatory impact and formulate actionable strategy, including taking “the big picture” view on various options
• Effective communication, keeping people well informed of plans, goals and objectives, and sharing information openly
• Responds to day-to-day issues and problems with simple, timely and practical solutions.

• Establish and maintain overview and exchange on current and evolving regulatory requirements in Europe, with primary focus on medicinal products.
• Provide expert regulatory input to strategic decision making, and ensure that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements, in close collaboration with Regulatory Operations and other internal stakeholders.
• Manage the maintenance activities potentially including Life Cycle Management strategy for medicinal products in Europe, and in collaboration with the Regulatory Operations.
• Ensure regulatory compliance and maintenance of all product registrations and licenses throughout the whole life-cycle of the products under his/her responsibility.
• Ensure timely submission of high quality responses to queries raised by regulatory agencies and follow up on these requests.
• Provide support to the Regulatory Affairs Managers in the hubs in topics related to medicinal products.
• Write comprehensible, clear Regulatory Assessments and documents for internal and external stakeholders (eg. Authorities and trade Associations).
• Ensure that regulatory submissions and other deliverables meet strict deadlines and fulfill European regulatory standards.
• Support in the development and implementation of regulatory standards that convey the best practices in the regulatory department.
• Establish strong relationships within the European organization, Regulatory Operations and Global Technology partners on a cross-functional basis including Marketing, Legal, Technical, Supply Chain, Regulatory and Product Safety, to ensure alignment and synchronization between Regulatory strategies and Business goals.
• Provide regulatory support on day-to-day regulatory issues, new initiatives and developments, including training to internal stakeholders and support to the Regulatory Affairs Managers in the hubs in topics related to the products and projects under his/her responsibility.
• Provide assistance to authority inspections in the matters under Regulatory responsibility.
• Represent CP’s interest in selected European and Local Trade Associations and share information with internal stakeholders.
• Ensure the review and approval of artworks and ingredient lists for products and regions under his/her responsibility.
• Provide input for budget preparation and reviews.
• Collaborate in regional and global regulatory projects and act as a project manager in the projects assigned to him/her.
• Contribute to an effective use of the network of regulatory consultants, including coordination with procurement and legal for contract negotiations and FCPA and Due Diligence processes.