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

CARBOGEN AMCIS AG; Bubendorf; Hybrid; CHF 150,000 - 190,000; Full time

Benefits offered by this job

Flexible working time

Work from home

5 weeks vacation

Childcare contributions

Travel insurance

13th month salary

Profit-sharing bonus

Job summary

CARBOGEN AMCIS AG in Bubendorf, Switzerland, seeks a Manager RAC (Regulatory Affairs & CMC) to support Drug Substance CMC projects and small molecules/ADCs. You will coordinate regulatory activities from development to market launch, and provide internal/external regulatory guidance.

You will author/regulate IND/IMPD/MAA/BLA submissions, manage post-approval changes, and lead CMC regulatory gap analyses. English required; German knowledge is a plus.

Qualifications

• Master/Engineering or Ph.D in Chemistry, Pharmacy or equivalent scientific discipline.
• Strong expertise in drafting IND/IMPD/MAA/BLAs from scratch; Japan accreditation is a plus.
• Good knowledge of cGMP regulations.
• Good knowledge of ICH guidelines for Small Molecules.
• At least 5 years' experience in the pharmaceutical industry/GMP environment with RA and CMC exposure.

Responsibilities

• Authoring/reviewing and maintaining Drug Substance CMC modules for INDs/IMPDs/MAAs/BLAs in line with authorities and customer needs.
• Assisting with post-approval change submissions.
• CMC regulatory assessments during change management (change controls, deviations).
• Regulatory support across pre-clinical to market launch and lifecycle management.
• Regulatory review of source documents for CMC docs.
• Lead/conduct project-specific CMC regulatory gap analyses.
• Manage accreditation in Japan.
• Collaborate with health authorities/customers: briefing docs and Q&A responses.
• Provide internal regulatory advice to project teams.

Skills

Regulatory Affairs

CMC development

Fluent English

German basics

Cross-functional teamwork

Education

Master or PhD in Chemistry/Pharmacy

Tools

Docubridge

eCTD

Job description

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

Your benefits:

• 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-sharingbonus

We look forward to receiving your application!