Regulatory Affairs Associate

No Relocation Assistance Offered
Job Number#172184 - Warsaw Mazovia Poland

Who We Are

Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specialising in Oral Care Personal Care Home Care Skin Care and Pet Nutrition. Our products are trusted in more households than any other brand in the world making us a household name!

Join Colgate-Palmolive a caring innovative growth company reimagining a healthier future for people their pets and our planet. Guided by our core valuesCaring Inclusive and Courageouswe foster a culture that inspires our people to achieve common goals. Together lets build a brighter healthier future for all.

Key Responsibilities

The Regulatory Affairs Assosiate Medical Devices will be responsible for executing regulatory strategies ensuring compliance and providing expert support across the European organization related to medical devices.

Regulatory Strategy Execution and Compliance:

• Ensure that regulatory strategies and regulatory operational activities are effectively executed to meet the business objectives and legal requirements in close collaboration with Regulatory Operations and other internal stakeholders.

• Provide expert regulatory input to strategic decision making.

• Manage the maintenance activities potentially including Life Cycle Management strategy for medical devices 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.

• Keep up-to-date with changes in regulatory legislation and guidelines.

• Establish and maintain overview and exchange on current and evolving regulatory requirements in Europe with primary focus on medical devices.

Submissions Documentation and Authorities:

• Ensure that regulatory submissions and other deliverables meet strict deadlines and fulfill European regulatory standards.

• Write comprehensible clear Regulatory Assessments and documents for internal and external stakeholders (e.g. Authorities and trade Associations).

• Ensure timely submission of high quality responses to queries raised by regulatory agencies and follow up on these requests.

• Provide assistance to authority inspections in the matters under Regulatory responsibility.

• Ensure the review and approval of artworks and ingredient lists for products and territories under his/her responsibility.

Internal Collaboration and Support:

• 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.

• Provide support to the Regulatory Affairs Managers in the hubs in topics related to medical devices.

• Communicate with business and technical partners to shape product development approaches to minimize regulatory impact (Marketing R&D Packaging CMS Legal).

• Support in the development and implementation of regulatory standards that convey the best practices in the regulatory department.

• Collaborate in regional and global regulatory projects and act as a project manager in the projects assigned to him/her (e.g. implementation of new IT systems review and update of SOPs).

• Provide input for budget preparation and reviews.

Required Competencies

Technical/Experience:

1. Relevant Master degree in Pharmacy Biology Chemistry or equivalent scientific discipline (minimum BSc or equivalent preferably with an MSc).

2. Minimum 3-5 years of Regulatory Affairs experience in an international environment in the field of Medical Devices.

3. Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation submission and maintenance of medical devices.

4. Good analytical skills and technical/ scientific competence.

Core Skills and Behavior:

• 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.

• Ability to think laterally innovate and adapt quickly to new demands and challenges (Managing Ambiguity).

• Team player proactive quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion.

• Responds to day-to-day issues and problems with simple timely and practical solutions.

Language:

• Fluency in English is required. Knowledge of another European language is highly valuable.

THIS IS A TEMPORARY POSITION FOR UP TO 2 YEARS

What we can offer:

• Salary Range: 13 500 PLN - 17 400 PLN gross per month
  
  

• Salary payment frequency: monthly
  
  

The salary level is determined by the objective evaluation of the positions requirements such as required skills effort responsibility and working conditions which places the role into a specific level within the companys compensation framework.

Employees will also be eligible to the annual bonus plan - on target 8% of base annual salary linked to company and individual performance.

The conditions of payment of the salary and benefits referred to above are regulated by the Employers Remuneration regulations which shall be submitted to employment candidates at the later stage of the recruitment process.

Benefits Package

• Group insurance and Medicover healthcare package (employee contribution is 1 PLN for each benefit monthly);

• Dental care subsidy;

• Sport card (Medicover Sport);

• Employee Capital Plan (PPK) with employer contribution above mandated one;

• Company Stock Saving Plan;

• Co-financing of meals in the amount of PLN 200 gross per month;

• Store with company products;

• Financial and in-kind rewards for additional achievements;

• Social Fund (holidays contribution prepaid cards for Christmas Majówka and Sport&Culture);

• Employee Assistance Program;

• Employee referral program;

Our Commitment to Inclusion
Our journey begins with our peopledeveloping strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self is treated with respect and is empowered by leadership to contribute meaningfully to our business.

Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race colour religion gender gender identity sexual orientation national origin ethnicity age disability marital status veteran status (United States positions) or any other characteristic protected by law.

Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation.

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