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CMC Services Regulatory Affairs Specialist

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Thermo Fisher Scientific

Nov 1

Applications are closed

  • Job
    Full-time
    Mid Level
  • Legal

Requirements

  • Graduation in Chemistry and Pharmaceutical Technology, Pharmacy, Biology, or Biotechnology
  • Confirmed experience (3 years) in a Regulatory Affairs department for an FDA approved pharmaceutical company, preferably manufacturers or Marketing Authorization Holders (MAH) of sterile products
  • Expertise in writing/reviewing CTD Module 3.2.P Drug Product for sterile medicinal products
  • Proficiency in EU/US and Rest of the World Submissions and handling documentation
  • Familiarity with Directives, Regulations, Italian Laws, cGMP, GMP Annex 1, ICH/EMA/FDA Guidelines
  • Good written and oral English skills
  • Analytical, communicative, and relational attitudes

Responsibilities

  • Support and collaborate with clients for the registration of Patheon Monza site as a manufacturer of sterile medicinal products
  • Assist clients in defining the regulatory strategy for Patheon Monza site registration
  • Write and review CTD Module 3.2.P Drug Product for new Marketing Authorizations, variations, renewals
  • Support clients in responding to Regulatory Authorities Deficiency Letters
  • Lead interactions with the Legal department and external services for notarization, legalization, and translation activities for Rest of the World registrations
  • Ensure compliance with Marketing Authorization/CTA requirements in manufacturing processes and testing
  • Ensure the registration dossier content is acknowledged in Patheon Monza site documentation by change controls
  • Conduct gap analysis before Regulatory Authority Prior Approval Inspections/clinical batch confirmation and identify appropriate corrective actions
  • Provide regulatory support to ensure compliance with relevant legislations, guidelines, and company policies
  • Support and participate to Regulatory Authorities inspections
  • Assist Regulatory Affairs Supervisor and Manager in editing reports requested by the EU Regulatory Affairs function and maintain RA database

FAQs

What is the work schedule for the CMC Services Regulatory Affairs Specialist position?

The work schedule is classified as "Other."

Where is this job located?

This position is located in Monza, Italy.

What qualifications are required for this role?

A graduation in Chemistry and Pharmaceutical Technology, Pharmacy, Biology, or Biotechnology is required, along with confirmed experience of at least 3 years in a Regulatory Affairs department for an FDA approved pharmaceutical company.

What specific experience is preferred for candidates?

Preference is given to candidates with experience in manufacturing or as a Marketing Authorization Holder (MAH) of sterile products.

What type of products will the Regulatory Affairs Specialist be working with?

The specialist will be focused on sterile medicinal products.

What are the main responsibilities of this position?

Key responsibilities include supporting the registration of Patheon Monza as a manufacturer of sterile medicinal products, writing and reviewing CTD Module 3.2.P, assisting clients with regulatory strategies, and ensuring compliance with regulatory requirements.

Are there any language requirements for this position?

Yes, good written and oral skills in English are required.

Will the Regulatory Affairs Specialist interact with Regulatory Authorities?

Yes, the specialist will lead interactions with Regulatory Authorities, respond to deficiency letters, support inspections, and assist in compliance measures.

What is the company's stance on diversity and inclusion?

Thermo Fisher Scientific values diversity and inclusion in its workforce and encourages individuals from all backgrounds to apply.

What additional skills are beneficial for this role?

Candidates should possess analytical, communicative, and relational skills.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.