Regulatory Affairs Officer for Finished Dosage Forms

Place of work

Agrate Brianza

Job description

Regulatory Affairs Officer for Finished Dosage Forms

Department: Regulatory Affairs

Main Activities expected by the Job:

1. 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.
2. Prepare regulatory documentation for Marketing Authorization (MA) renewals, Annual Reports, and responses to deficiency letters from health authorities.
3. Manage regulatory documentation in eCTD software.
4. Collaborate with internal departments and external suppliers to obtain the technical documentation to perform the activities above described.
5. Monitor of regulatory requirements and guidelines to ensure compliance with evolving regulations and industry standards.
6. Manage the preparation and revision of the artworks for products held by the company.
7. Manage the Technical Sheets with customers and manufacturers.
8. 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.
9. Participate, together with the RA Specialist/Manager, in teleconferences and meetings with customers and/or internal departments..
10. Archive dossiers, relevant amendments, and regulatory documents.
11. Translate documentation (e.g. procedures, batch records, various documents).

Technical Skills expected by the Job:

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

Behavioral Skills Expected by the Job :

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

Computer Skills expected by the Job (type of tool and level of expertise):

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

Languages Skills expected by the Job:

Good to excellent knowledge of the English language:

Writing: B2/C1 level

Speaking/Listening: B2 level

Mandatory Requirements of the Job (education level, certifications, years of seniority):

1. Bachelor’s degree in a scientific or related field (such as Chemical and Pharmaceutical Technologies, Pharmacy, Biology, Chemistry, or Biotechnology).
2. RA Master’s degree preferred.
3. The candidate must live within 30 km of the workplace or be willing to relocate nearby within 3 months.
4. Previous experience in regulatory affairs for pharmaceutical finished dosage forms is a plus