Regulatory Affairs Project Specialist - System Vimercate

Regulatory Affairs Project Specialist - System
Vimercate
Lombardia, Vimercate

Ecolab, Purolite Resins, the world leader in resin-based separation, purification and extraction technology, is seeking a **Senior **Regulatory Affairs Specialist**.

We manufacture products which help our customers around the globe, mainly in pharmaceutical and life science sectors, with technology which are critical to safe manufacture of their products. It's an exciting business which helps make the world cleaner, safer and healthier.

Are you passionate about regulatory compliance, business growth and project management? We are looking for a dynamic **Senior Regulatory Affairs Specialist** to lead our BPT divisional Regulatory business readiness activities for the SAP Global implementation. This is a fantastic opportunity to make a significant impact on our organization by ensuring compliance with all relevant regulatory requirements and standards.

**What's in it For You**:

- The opportunity to take on some of the world's most meaningful challenges, helping customers achieve clean water, safe food, abundant energy and healthy environments

- The ability to make an impact and shape your career with a company that is passionate about growth

- The support of an organization that believes it is vital to include and engage diverse people, perspectives and ideas to achieve our best

**Why choose Ecolab?

- A world-leading international organization, benefitting from a diverse, multinational team

- A fast-paced, dynamic, and rapidly growing environment

- Manufacture of high-quality technical products, developed hand-in-hand with leading minds in the industry

- Entrepreneurial workplace culture with a flat management structure, encouraging new approaches and ideas

**What You'll Do**:

- Lead the Regulatory business readiness activities for SAP Global implementation.

- Work with Regulatory teams, such as Product Safety, Transport Classification, and Registration & Approvals during SAP EHS implementation to ensure processes to be compliant with all relevant regulatory requirements and standards.

- Lead in setting up processes within SAP/specification system for highly regulated Pharma products, including Active Pharmaceutical Ingredients (API).

- Manage and coordinate project activities to ensure timely and successful implementation.

- Collaborate with cross-functional teams to align regulatory strategies with business objectives.

- Monitor and report on project progress, identifying and mitigating risks as necessary.

- Provide regulatory guidance and support to project teams throughout the implementation process.

- Partner with various functions such as the Specification team, Quality, Marketing, Supply Chain, and others to identify processes and appropriate review steps for SAP implementation.

**What you'll need**:

- Master's degree in relevant fields

- Proficiency in English (written and oral)

- Ability to analyse regulatory data and provide actionable insights.

- Strong project management and problem-solving skills to address project challenges

- Excellent communication and collaboration skills to work effectively with various global teams

- Ability to align regulatory strategies with business objectives and drive successful project outcomes.

- Ability to adapt to a fast-paced, dynamic, and rapidly growing environment.

- Experience in Regulatory Affairs or in the context of ERP implementations such as SAP EHS (Environment, Health, and Safety)

- Work independently, agile, results-oriented, and self-motivated

- Goal-oriented, pragmatic, meticulous working style, high attitude to quality

- Work experience in multi-cultural/multi-national organizations is highly desired, and cultural awareness a given

- Willingness to travel to different parts of the world depending on business needs - expenses covered

**Our Commitment to Diversity and Inclusion

Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. Our goal is to fully utilize minority, female, and disabled individuals at all levels of the workforce. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability.