Job Description

Job Id
289651
Eysins, Vaud, Switzerland
Job Type
full-time, part-time possible

Work Your Magic with us!



Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.



United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.



Your role:


You are responsible for driving all CMC Regulatory activities for assigned large molecules (biotech) commercial products and projects worldwide. In this role you develop, author and own the relevant Global Regulatory CMC Life Cycle Strategy and all CMC Dossier types, such as NDAs/MAAs, variations, amendments, renewals, annual reports, and answers to health authority questions.


You serve as the contact point for CMC Regulatory topics and act as liaison in-between technical CMC-, quality-, supply- and Regulatory Affairs functions and provide strategic support and advice to the CMC team, the Global Regulatory Strategy Team (GRST), the Global Product Supply Team (GPST), and other cross-functional project teams (e.g. Tech Transfer Project Team). Upon collecting and interpreting country-specific regulatory CMC requirements you translate them into deliverables. You plan and align CMC Regulatory activities and develop submission roll-out and implementation plans, in close collaboration with key stakeholders.


You are the expert for CMC regulations, guidance, regulatory trends and competitive environment, including accelerated pathways, and CMC innovations and lead and participate in internal and cross-functional, international initiatives.



Who you are:



University degree in Life Sciences such as Biochemistry, Biotechnology or a related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline) 4 to 9 years of CMC regulatory and/or CMC technical experience within the pharmaceutical / biotech industry (e.g. in regulatory affairs, quality control, analytical development or manufacturing / process development) Ability to develop and prepare successful regulatory CMC strategies for variations, renewals, or new registrations (new MAAs) Experience in preparation and management of regulatory CMC documentation, such as a full international submission (new product application) or complex variations Practical experience in one of the following areas: manufacturing process development, technical transfers, validation or analytical development, control strategies Sound understanding and in-depth knowledge of global pharmaceutical legislation Ability to work in teams, good interpersonal skills Assertive, proactive, flexible, speak up personality Ability to think strategically
Excellent written and spoken communication skills in English (knowledge of other European languages such as French, Italian or German is an asset)
Please note that this position does not support full remote work

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!



and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!





US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information here.



Applicant Profile

Along with our brand-new career site, we've also revamped our application process. If you've applied for a position before April 16th 2025, you can log into your old profile to see the status of past applications. For the application you've will completed, and any in the future, you can create a new profile to check in on your status.
WHAT WE OFFER
Money makes the world go round. But at our company there's more than just financial rewards. We offer a range of attractive benefits to help you work your magic.
Saving & Finacial
Our 401(k) Plan includes a generous company-matching contribution and an additional discretionary contribution each year.
We also provide tax-advantaged accounts for you to save for healthcare, commuting expenses, company-provided and buy-up life insurance to help you protect your financial future.
Health & Wellness
We offer comprehensive medical, dental, & vision coverage-including virtual care through Telehealth & free behavioral health counseling sessions through our Employee Assistance Program.
We also offer a wellness incentive program and personalized support to help you navigate and use your benefits.
Voluntary Benefits
Our voluntary benefits provide additional protection from the high costs of healthcare not covered by health insurance.
We also have discount programs that offer exclusive savings on everything from auto, home, and pet insurance to low-interest personal loans.
Work/Life Support
We have several programs to support your work/life balance, including generous paid time off, back-up day care services, education assistance, and more.
OUR RECRUITING PROCESS
Depending on the position (level, functional area, country) the process can vary slightly.
You apply
Complete your online application for your preferred role(s) that match your interests and qualification. If you cannot find a suitable role please join our Talent Zone and stay connected for your next career opportunity.
We screen
We review your application and if we determine that you are a good fit we will move you to the selection process.
We assess
You are interviewed by phone, via video and/or face to face.
Mutual agreement
Ideally you are the perfect match for us! We hope you consider us as your new employer.
Work your magic!
To guarantee you a smooth start our onboarding preparation begins.
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