Regulatory Affairs - Publishing And Data Management Support

Buscojobs; Sicilia; Remoto; EUR 35.000 - 65.000; Tempo pieno

Descrizione del lavoro

Join a forward-thinking consulting firm as a Regulatory Affairs Consultant, where you'll play a vital role in ensuring compliance within the pharmaceutical and medical device industries. This exciting position involves preparing and managing regulatory documentation, collaborating with cross-functional teams, and interfacing with regulatory authorities. You'll be part of a dynamic team that values attention to detail and proactive problem-solving. Enjoy the flexibility of full remote work while contributing to impactful projects that shape the future of healthcare. If you're ready to make a difference in a global setting, this opportunity is for you.

Servizi

Permanent Contract

Competitive Salary

Travel Bonuses

Full Remote Work

Competenze

• 2-5 years of experience in the pharmaceutical regulatory sector.
• Familiarity with global regulatory frameworks and publication guidelines.

Mansioni

• Assist in the preparation and submission of regulatory documentation.
• Perform quality checks and reviews of regulatory documentation.

Conoscenze

Regulatory Documentation Preparation

Attention to Detail

Communication Skills

Project Management

Familiarity with Regulatory Frameworks

Formazione

Degree in Pharmacy

Degree in Biotechnology

Strumenti

docuBridge

eCTD Manager

drugTruck

Veeva

Documentum

eDMS

Descrizione del lavoro

Job Opening: Regulatory Affairs Consultant for Publishing and Data Management Support

Join PQE Group, a leading global consulting company in the pharmaceutical and Medical Device industry, established in 1998 with a strong international presence through 45 branches and 2,000 employees across Europe, Asia, and the Americas. We are seeking a Regulatory Affairs Consultant to support our growing Regulatory Affairs team in Italy.

Key Responsibilities:

1. Assist in the preparation, publication, and submission of regulatory documentation, including eCTD submissions using tools like docuBridge and eCTD Manager.
2. Manage regulatory documentation and data using RIMS and eDMS systems such as drugTruck, Veeva, and Documentum.
3. Support data management processes for xEVMPD / ISO-IDMP / SPOR via relevant regulatory portals.
4. Collaborate with cross-functional teams to ensure accurate regulatory submissions in compliance with guidelines and standards.
5. Perform quality checks and reviews of regulatory documentation for accuracy and completeness.
6. Stay updated on regulatory guidelines, best practices, and industry trends related to documentation submission.
7. Provide training and support for internal and external stakeholders on regulatory portals and tools.
8. Interface with regulatory authorities and external vendors to resolve issues related to regulatory tools.

Candidate Profile:

• Degree in Pharmacy, Biotechnology, or related field.
• 2-5 years of experience in the pharmaceutical regulatory sector.
• Familiarity with global regulatory frameworks and publication guidelines.
• Proficiency in publication software such as eDMS, docuBridge, eCTDManager, and Veeva.
• Attention to detail, organizational skills, and ability to manage multiple projects.
• Excellent communication and interpersonal skills.
• Proactive and adaptable to evolving regulatory landscapes.
• Willingness to travel up to 30% of the time.

What We Offer:

• Permanent contract with competitive salary based on experience.
• Travel bonuses for client visits.
• Full remote work from Italy.

Next Steps:

Apply now! If selected, our HR team will contact you for an initial interview, followed by a technical interview with the hiring manager. Successful candidates will discuss further steps or offers. We look forward to your application and the possibility of welcoming you to our international team!