Regulatory Affairs Officer

JR Italy; Monza; Ibrido; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Regulatory Affairs Officer to join their dynamic Regulatory Department. This role offers hybrid work flexibility, allowing for a balance between office and remote work. The ideal candidate will possess a strong background in regulatory affairs, particularly in pharmaceutical finished dosage forms, and will be responsible for preparing submissions, managing documentation, and ensuring compliance with EU and FDA regulations. Join a forward-thinking company where your expertise will contribute to the development of innovative healthcare solutions.

Competenze

• 2-3 years of experience in regulatory affairs for pharmaceutical products.
• Bachelor's degree in Chemistry, Pharmacy, Biology, or related field.

Mansioni

• Prepare and submit regulatory submissions to health authorities.
• Manage regulatory documentation and ensure compliance.

Conoscenze

Regulatory Affairs

Attention to Detail

Time Management

Problem-Solving

Communication Skills

Formazione

Bachelor's degree in a scientific field

RA Master's degree

Strumenti

eCTD software

Office Suite (Word, Excel, Outlook, PowerPoint, Adobe Acrobat)

Descrizione del lavoro

Social network you want to login/join with:

Client:

ACS DOBFAR

Location:

Job Category:

Other

EU work permit required:

Yes

Job Reference:

763555398507980390433711

Job Views:

1

Posted:

02.05.2025

Expiry Date:

16.06.2025

Job Description:

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. This position offers hybrid work flexibility, including 10 days of Smart Working per month in accordance with the company's policy.

Position:

Regulatory Affairs Officer for FINISHED DOSAGE FORMS

Experience:

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

Main Activities:

• Prepare and submit regulatory submissions to health authorities, including ANDAs, NDAs, MAAs, INDs, and variations/supplements.
• Prepare documentation for MA renewals, Annual Reports, and responses to deficiency letters.
• Manage regulatory documentation in eCTD software.
• Collaborate with internal and external partners to obtain technical documentation.
• Monitor regulatory requirements to ensure compliance.
• Manage artworks and technical sheets for products.
• Support changes to drug substance and drug product manufacturers.
• Participate in teleconferences and meetings with stakeholders.
• Archive dossiers and regulatory documents.

Technical Skills:

• Good knowledge of EU and FDA regulations, ICH guidelines, and regional requirements.
• Basic knowledge of GMP and analytical methods (preferred).

Behavioral Skills:

• Attention to detail, independence, and teamwork skills.
• Time management and ability to handle multiple tasks.
• Strong communication and problem-solving skills.

Computer Skills:

• Proficiency in Office Suite (Word, Excel, Outlook, PowerPoint, Adobe Acrobat).
• Experience with eCTD system (Extedo software).

Languages:

Good to excellent English skills (B2/C1 level in writing).

Mandatory Requirements:

• Bachelor's degree in a scientific or related field (e.g., Chemistry, Pharmacy, Biology, Biotechnology).
• RA Master's degree preferred.
• Residency within 30 km of the workplace or willingness to relocate.