Regulatory Affairs Officer

Overview

ACS DOBFAR S.p.A., an Italian multinational leader in the production of APIs and Finished Products, is looking for a Regulatory Affairs Officer to join the Regulatory Department based in Agrate Brianza. For this position, hybrid work is possible, offering flexibility. Employees are entitled to 10 days of Smart Working per month in accordance with the company's Smart Working Policy.

Position : Regulatory Affairs Officer for FINISHED DOSAGE FORMS

• A minimum of 2 to 3 years of experience in regulatory affairs for pharmaceutical finished dosage forms is required

Responsibilities

• Prepare and submit regulatory submissions to health authorities, including Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Investigational New Drug (IND) applications, and variations / supplements.
• Prepare regulatory documentation for Marketing Authorization (MA) renewals, Annual Reports, and responses to deficiency letters from health authorities.
• Manage regulatory documentation in eCTD software.
• Collaborate with internal departments and external suppliers to obtain the technical documentation to perform the activities above described.
• Monitor regulatory requirements and guidelines to ensure compliance with evolving regulations and industry standards.
• Manage the preparation and revision of the artworks for products held by the company.
• Manage the Technical Sheets with customers and manufacturers.
• Support the management of changes to drug substance and drug product manufacturers for all relevant markets, using company management systems, including communication with customers and relevant follow-up until approval by health authorities / customers.
• Participate, together with the RA Specialist / Manager, in teleconferences and meetings with customers and / or internal departments.
• Archive dossiers, relevant amendments, and regulatory documents.
• Translate documentation (e.g. procedures, batch records, various documents).

Technical Skills

• Good knowledge of regulatory requirements and guidelines, including EU and FDA regulations, ICH guidelines and regional regulatory requirements in multiple geographic regions.
• Basic knowledge of GMP and analytical methods (preferred)

Behavioral Skills

• Ability to work with precision, independently and collaboratively in a fast-paced, dynamic environment.
• Good time management skills to handle multiple activities while respecting deadlines.
• Strong communication skills with internal teams and customers.
• Effective problem-solving skills

Computer Skills

• Good knowledge of the Office Suite (Word, Excel, Outlook, PowerPoint, Adobe Acrobat)
• Knowledge and management of the eCTD system (Extedo software)

Languages

• Good to excellent knowledge of the English language
• Writing : B2 / C1 level
• Speaking / Listening : B2 level

Education and Requirements

• Bachelor's degree in a scientific or related field (such as Chemical and Pharmaceutical Technologies, Pharmacy, Biology, Chemistry, or Biotechnology).
• RA Master’s degree preferred.
• The candidate must live within 30 km of the workplace or be willing to relocate nearby within a short time.