Regulatory Affairs Manager

Manpower Professional, a division of Manpower Group, dedicated to the search and selection of Middle Management profiles, is looking for an experienced Regulatory Affairs & Quality Specialist, for medium-sized company, COATING INDUSTRY.

The role is responsible for formulating and developing regulatory strategies and ensuring that regulatory compliance is maintained or enhanced to meet business objectives and legal requirements.

Being role's major accountabilities:
Regulatory Affairs
- Manage the activities of Regulatory Affairs ensuring the implementation of appropriate and effective regulatory strategies.
- Liaise and negotiate with regulatory authorities for price & reimbursement and regulatory items.
- Manage activities such as audits and regulatory agency inspections.
- Provide expert regulatory input to strategic decision making, including portfolio review, prioritization, budgets and external communications.
- Review product artworks and marketing materials such advertising and literature, to ensure that regulatory requirements are met.
- Develop and establish policies and standards that convey the best practices in the company, defining when necessary Standard Operation Procedures (SOPs)
- Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfill European regulatory and quality standards.
- Keep up-to-date with changes in regulatory legislation and guidelines.

Quality
- Review technical agreements.
- Manage activities such as audits, regulatory agency inspections, product recalls/complains/OOS/Deviation/defects/rework/repack, together with manufacturers involved.
- Track and process any quality commuication received.
- Write and revise local SOPs for quality.
- Training employees in quality issues.

WHAT WE REQUIRE
- Proven at least 5 years experience in managing regulatory affairs in Chemical industry at senior level
- In depth knowledge of European chemical legislation, relevant guidelines, procedures and requirements
- In depth knowledge of Regulatory REACH
- Degree in Scientific Disciplines (mainly Pharmacy, Chemistry and Pharmaceutical Technology, Biology)
- Good command of English

Contratto a tempo indeterminato e ottime possibilità di crescita economica e professionale

Sede di lavoro: BELLUSCO (MB)

Contratto di lavoro: Tempo indeterminato

Stipendio: €40.000,00 - €50.000,00 all'anno

Orario:

- Dal lunedì al venerdì