Manufacturing Regulatory Specialist

Are you ready to make an impact at the intersection of manufacturing and regulatory strategy?
Join us as a Manufacturing Regulatory Specialist and play a central role in ensuring compliance, supporting quality excellence, and enabling innovation across our production network.

Role Overview

The Manufacturing Regulatory Specialist plays a key role in ensuring regulatory compliance across all manufacturing-related processes and documentation. This position actively supports quality events management, continuous improvement initiatives, and the regulatory strategy for new product introductions and technology transfers.

Key Responsibilities

• Evaluate the regulatory impact of changes and/or corrective actions in response to quality events (deviations, complaints).

• Coordinate the drafting, review, and collection of regulatory documentation to support quality variations, Deficiency Letters, and regulatory submissions for new products and technology transfers.

• Ensure regulatory compliance between manufacturing practices and reference dossiers; identify gaps and support recovery planning.

• Draft, maintain, and regularly update regulatory documentation in line with current legislation and best practices.

• Contribute to the continuous improvement of the company’s quality management system, in compliance with GMPs and Marketing Authorizations.

• Support during regulatory and client inspections, and contribute to post-inspection activities, ensuring timely resolution of non-conformities.

• Provide regulatory guidance for business development initiatives, including due diligence on new products and technology transfers at the plant level.

• Manage regulatory documentation and customer communication related to contract manufacturing activities.

• Support cross-functional teams in investigations related to quality events (deviations, complaints, OOS/OOT), identifying CAPAs and evaluating their regulatory impact.

• Collaborate with Procurement in the selection and qualification of new third-party manufacturers and suppliers of strategic materials, ensuring compliance and operational efficiency.

• Perform all activities in full compliance with the company’s Code of Ethics, Organizational Model pursuant to Legislative Decree 231/2001, and privacy regulations (Legislative Decree 196/2003).

Requirements

• Degree in CTF (Pharmaceutical Chemistry and Technology), Chemistry, or Industrial Chemistry. A Master’s in Regulatory Affairs is considered a plus.

• At least 3 years of experience in regulatory affairs within the pharmaceutical industry (national or international), ideally in manufacturing sites of Finished Products and/or APIs.

• Experience managing client relationships in contract manufacturing.

• Excellent English proficiency; strong command of statistical and digital tools.

• Results-oriented, capable of working independently and managing responsibilities proactively.

• Excellent communication and teamwork skills.

• Willingness to travel up to 20%.