Manager RAC (Regulatory Affairs and CMC) (m/w/d)

CARBOGEN AMCIS AG; Bubendorf; Hybrid; CHF 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

13th month salary

Profit-sharing bonus

5 weeks vacation or more

Childcare contribution

Private accident insurance

Travel insurance for private trips

Zusammenfassung

CARBOGEN AMCIS in Bubendorf, Switzerland, seeks a Manager RAC (Regulatory Affairs & CMC) to join the corporate RAC and local Swiss team. You will manage regulatory activities for Drug Substance projects, including CMC for small molecules and ADCs, from development to market launch and lifecycle.

You will coordinate submissions, provide regulatory advice, and drive CMC development with cross-functional teams, including global health authorities and customers.

Qualifikationen

• Master/Ph.D in Chemistry, Pharmacy or equivalent.
• Strong regulatory affairs expertise for Drug Substance with CMC focus.
• Drafting IND/IMPD/MAA regulatory files from scratch.
• Good knowledge of cGMP and ICH guidelines for small molecules.
• 5+ years in pharma/GMP with regulatory affairs and CMC exposure.
• Fluency in English; basic German recommended.

Aufgaben

• Authoring, reviewing and maintaining Drug Substance CMC documents for registrations.
• Assist with post-approval change submissions.
• Regulatory assessment for change control and deviations.
• CMC regulatory support across preclinical to market launch and lifecycle.
• Regulatory review of source documents for CMC documentation.
• Lead or conduct CMC regulatory gap analyses for small molecules.
• Coordinate with Health Authorities and customers on filings.
• Provide regulatory advisory support to internal teams and projects.

Kenntnisse

Regulatory Affairs

CMC development

IND/IMPD/MAA/BLAs drafting

ICH guidelines

GMP/cGMP knowledge

English fluency

Regulatory project coordination

eCTD submission software (Docubridge)

Ausbildung

Master / Engineering or Ph.D in Chemistry/Pharmacy

Tools

Docubridge

eCTD submission

Jobbeschreibung

Manager RAC (Regulatory Affairs and CMC) (m/w/d)

We are offering a new challenge as Manager RAC (Regulatory Affairs & CMC) at our site in Bubendorf, Switzerland.
You will be a member of the corporate RAC and part of local Swiss regulatory affairs and CMC team dedicated to Drug Substance Business Unit. You will support customer activities focusing on Chemistry Manufacturing and Controls (CMC) for small molecules project mainly and ADCs/Bioconjugates derivatives.
In this very dynamic and hands-on role, you will work collaboratively with the other departments to coordinate the regulatory activities from clinical development up to market launch and life cycle management. You will provide regulatory support/advice internally and to external customer projects related.

Your responsibilities:

• Authoring/reviewing and maintaining registration documents (Drug Substance CMC Quality Module / sections for INDs, IMPDs, MAAs and/or BLAs) in accordance with the requirements of the authorities and customers requirements as well as international guidelines
• Assisting with the submission of post-approval change documentation
• Regulatory assessment in terms of change management (change controls, deviations)
• CMC regulatory support during the entire process and product development from the pre-clinical via the clinical phases to market launch, internally and in relation to customer projects / attending customer meetings and project team meetings
• Performing a regulatory review of the source documents in support of the CMC documentation
• Leading and/or conducting project specific CMC regulatory gap analysis as driver for CMC development (mainly small molecules drug substance)
• Managing accreditation in Japan
• Collaboration with the Health Authorities / customers: preparing briefing documents, answers to questions from authorities on submitted registration documents
• Regulatory affairs advise and hands-on support internally for improvement and customer oriented regulatory projects

Your profile:

• Master / Engineering or Ph.D degree in Chemistry, Pharmacy or equivalent scientific discipline
• Good understanding of regulatory affairs for Drug Substance with a strong focus on CMC development for small molecules (traditional CMC development versus accelerated development program) - You have expertise in drafting IND/IMPD/MAA regulatory files from scratch ; experience in regulations & accreditation in Japan is an added value
• Good knowledge of cGMP regulations
• Good knowledge of ICH guidelines and regulatory requirements for Small Molecules
• At least 5 years experience in the pharmaceutical industry / GMP environment: several years in a Regulatory Affairs department combined with previous CMC (R&D, Operations, Analytics) function
• Previous experience in CDMO or working in customer projects is a clear advantage
• Team oriented, pro-active / problem-solving mentality, service-oriented mindset with flexibility to handle multiple tasks, flexible working ‘attitude’
• Good coordination and communication skills – Fluency in English required; Basic knowledge German is recommended
• Good sense of responsibility and reliability
• Knowledge of eCTD submission software (Docubridge) is an advantage
• A dynamic working environment with high-quality infrastructure
• Flexible working time model with a 40-hour week and the possibility to work from home
• Interesting opportunities to expand your professional knowledge
• At least 5 weeks of vacation
• Contribution to childcare costs
• Travel insurance for private trips
• Privately insured in the event of an accident
• 13th month's salary, with 100% of the social deductions covered by CARBOGEN AMCIS
• If the financial year is successful, there is a profit-sharing
  bonus

Note for recruitment agencies: We do not accept unsolicited applications from recruitment agencies for this position. Unsolicited applications from recruitment agencies will be deleted and not be processed further. Thank you for your understanding.

• CARBOGEN AMCIS is a leading service provider in the area of product and process development, including the commercial production of active ingredients for the pharmaceutical and biopharmaceutical industries. We have 4 facilities across Switzerland (Aarau, Hunzenschwil, Bubendorf, and Vionnaz), as well as locations in St-Beauzire (FR), Manchester (UK), Shanghai (CN) and Veenendaal (NL). Our success is based on the high professional and personal competence of our employees. Learn more about careers opportunities at CARBOGEN AMCIS at: www.carbogen-amcis.com/careers