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Open nowPosted 2 days ago

Regulatory Specialist - Clinical / Early-Stage Development (CMC) (m/f/d)

Work Selection

Where
BASEL, BS, Switzerland
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Your applicationOpen nowRegulatory Specialist - Clinical / Early-Stage Development (CMC) (m/f/d)Work Selection · BASEL, BS, Switzerland

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This job: posted 2 days ago

The posting

Seniority Level

Mitarbeiter

Berufskategorie

Pharma & Chemie & Life Science

Stellenprozent

100 %

Jobtyp

Temporär

Referenz-Nr.

AFE-PC-T-57657

Beschreibung ###

As a first-tier supplier to our renowned business partner F. Hoffmann-La Roche Ltd. in Basel, we are currently looking for a motivated and dedicated Regulatory Specialist - Clinical / Early-Stage Development (CMC) for a temporary assignment of 12 months.

A healthier future. It-s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

That-s what makes us Roche.

At Roche, we believe in empowering you to thrive and do your best work. By bringing together our unique strengths in technical regulatory affairs, medicines, and technology, you will collaborate in an environment that nurtures growth, values your unique perspective, and drives sustainable innovation to transform healthcare for patients worldwide.

In the position of Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR), you will be accountable for handling Health Authority interactions pertaining to CMC information, including IND, IMPD and related clinical regulatory submissions.

This position is specifically focused on early clinical development, supporting Investigational Medicinal Products (IMPs), Investigational Medicinal Product Dossiers (IMPDs) and Clinical Trial Applications (CTAs).

The role requires strong technical CMC regulatory expertise, close collaboration with global stakeholders and proficiency in Veeva Document Management to support compliant regulatory submissions.

Tasks & Responsibilities ###

  • Independently manage and execute global technical regulatory submissions for clinical products, ensuring compliance with local and regional registration requirements, internal policies and audit standards.
  • Support CMC regulatory activities for early clinical development programs.
  • Prepare and coordinate IMPDs and other technical documentation required for Clinical Trial Applications.
  • Support regulatory strategies aimed at enabling timely approval of CTAs.
  • Evaluate technical information and changes for potential regulatory impact.
  • Maintain CMC documentation within Veeva Document Management.
  • Represent Pharma Technical Regulatory on cross-functional project teams and provide regulatory advice.
  • Collaborate with global technical teams, affiliates and other stakeholders.
  • Support interactions with Health Authorities and external partners on assigned technical topics.
  • Identify regulatory risks and support improvements to submission processes and workflows.
  • Monitor relevant changes in global regulatory requirements and assess their potential impact on development programs.

Must Haves ###

  • Minimum Bachelor-s degree in a relevant field
  • 3-4 years of CMC regulatory / technical regulatory experience
  • Experience in CMC regulatory support for early clinical trials
  • Experience with Investigational Medicinal Products (IMPs)
  • Hands-on experience preparing or supporting Investigational Medicinal Product Dossiers (IMPDs)
  • Experience with Clinical Trial Applications for early- to mid-stage development programs
  • Solid hands-on experience with Veeva Document Management for regulatory submissions
  • Fluent English, written and spoken, minimum C1

Nice to Haves ###

  • German language skills
  • Previous Roche experience
  • Experience with biologics

Benefits ###

  • Work with modern and up-to-date tools in an innovative work environment
  • Experience a work culture that promotes diversity and inclusion and where all employees feel valued
  • Benefit from financial support for your professional development plans
  • Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
  • Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card
  • Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
  • Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
  • Take advantage of attractive fitness and swimming pool facilities or the gaming room as a creative retreat
  • Enjoy a selection of high-quality meals in modern staff restaurants
  • As part of a sustainable mobility concept, on-site parking spaces are available to you, provided you meet the relevant qualifications
  • Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days

Are you interested? Don't hesitate and submit your complete application documents online today.

We look forward to hearing from you!

Posting text belongs to the employer. Removal requests: contact us.

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