Regulatory Affairs Consultant

Amaris Consulting | Part of Mantu; Latina; On-site; EUR 26,000 - 50,000; Full time

Benefits offered by this job

International community

Internal Academy training

Team events and activities

Well-being and work-life balance

Job summary

Amaris Consulting | Part of Mantu is seeking a Regulatory Affairs Consultant for a fully onsite position in Latina, Italy. You will draft and review CTD Module 3 quality sections, prepare documentation for new marketing authorisations and support clients through registrations and responses to deficiency letters.

You should have a degree in a relevant scientific field and prior regulatory affairs experience focusing on CMC and CTD Module 3, with strong English (and Italian at least C2).

Qualifications

• Experience in pharmaceutical Regulatory Affairs with focus on CMC documentation and CTD Module 3.
• Knowledge of CTD structure, especially Module 3 and the Quality section.
• English written and spoken; Italian native or C2 level.

Responsibilities

• Draft and review Quality and CMC sections of regulatory dossiers, focusing on Module 3 of the CTD.
• Prepare and update pharmaceutical quality documentation for new marketing authorisation applications.
• Provide regulatory support to clients during new registration processes.
• Assist in preparing responses to Deficiency Letters from regulatory authorities.
• Review manufacturing, control and validation data included in regulatory submissions.
• Assess documentation related to sterile pharmaceutical manufacturing processes.
• Collaborate with clients, manufacturing sites, Quality teams and regulatory stakeholders.
• Contribute to clear, accurate regulatory responses.

Skills

Regulatory Affairs

CTD Module 3

CMC documentation

English proficiency

Italian language (native or C2)

Education

Degree in Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biotechnology or related field

Job description

Would you like to start a new professional adventure as a Regulatory Affairs Consultant in one of our opportunities in the Life Sciences industry in Latina (fully onsite position) ?

• Draft and review Quality and CMC sections of regulatory dossiers, with a focus on Module 3 of the CTD.
• Prepare and update pharmaceutical quality documentation for new marketing authorisation applications.
• Provide technical and regulatory support to clients during new registration processes.
• Support clients in preparing responses to Deficiency Letters issued by regulatory authorities.
• Review manufacturing, control and validation data included in regulatory submissions.
• Assess documentation related to sterile pharmaceutical manufacturing processes.
• Collaborate with clients, manufacturing sites, Quality teams and regulatory stakeholders.
• Contribute to the preparation of clear, accurate and consistent regulatory responses.
• Degree in Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biotechnology or a related scientific field, or equivalent experience.
• Previous experience in pharmaceutical Regulatory Affairs, with a focus on CMC documentation and CTD Module 3.
• In-depth knowledge of the CTD structure, particularly Module 3 and the Quality section.
• Good knowledge of validation processes for sterile pharmaceutical manufacturing, including Process Validation, Media Fill, Cleaning Validation and Sterilization Validation.
• Good knowledge of English, both written and spoken. Italian native or C2 level.

What do we offer?

• An international community bringing together more than 110 nationalities.
• An environment where trust is central and internal growth is valued.
• A solid training system with an internal Academy and available learning modules.
• An active workplace with internal events, team building activities and dedicated initiatives.
• A strong commitment to well-being and work-life balance.

Local benefits in Italy:

• Flexible working options according to project requirements and company policy.
• Health insurance and well-being programmes, where applicable.
• Gross Annual Salary (Range: EUR 26,000 – EUR 50,000).
• The salary range will be determined using objective and gender-neutral criteria.
• During the recruitment process, we won’t ask for information about your current or previous salary.

Our salary ranges are intentionally wide, because we hire talented minds, not “templates”. The same role can attract very different candidates, and we believe in leaving room for that. What lands within the range depends on your specific experience, skills and what you bring to the role.

The ideal person shares these values:

Boldness: our entrepreneurial spirit of adventure is what brings us together and drives our success.

Trust: trust is the foundation of our relationships and enables us to promote freedom of expression, creativity and new ideas.

Performance: it guides us in our continuous improvement and in our drive to achieve concrete results.

Commitment: we work with dedication and responsibility to meet our objectives.

Independence: Amaris Consulting belongs to those who created it and to those who develop it every day.

With your application, you may have the opportunity to join a company that supports its partners in the Pharmaceutical, Biotechnology and Medical Device sectors, with activities covering Quality Control, Quality Assurance, GMP compliance, analytical and process validation, regulatory support, manufacturing excellence and R&D.

Diversity and inclusion: Amaris Consulting promotes equal opportunities and assesses applications based on skills, experience and potential. We welcome qualified applications without discrimination based on gender, gender identity or expression, sexual orientation, ethnic origin, nationality, religion or belief, age, disability, marital or family status, or any other protected characteristic.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.