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Team Lead Pharma Registration Germany, Life Science (all genders)
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: As Head of Pharma Registrations Germany in LS Regulatory organization you will be responsible to plan and handle regulatory activities for both new and existing products such as active pharmaceutical ingredients, excipients, process materials for pharmaceutical production (e.g., cell culture media, enzymes) used in formulation and/or up/down stream (biopharma process). You run the preparation of technical files for registrations according to authority requirements in the country / region of submission (DMF, CEP, ASMF). You work in a global setup to ensure site registrations worldwide and notification of products at manufacturing sites that produce LS products. This includes compliance to import and export requirements and management of related authority fees (e.g., GDUFA registration fees). As member of an international and interdisciplinary team, you will also be responsible to design and implement policy and workflows in collaboration with the local units of the sites, local agents and subsidiaries. You are responsible to follow-up and inform about new and upcoming regulations and to initiate related activities for implementation relevant to the intended use of substances for pharmaceutical use manufactured at the LS sites in Germany. You will be the regulatory liaison partner with Commercial, Manufacturing sites, Operations, Distribution, Trade Compliance, QA, QC and Regional Regulatory units. You will guide peers and middle management regarding regulatory issues and challenges within his/her subject area. In addition, you will provide regulatory support and guidance to marketing and commercials via seminars / trainings / events. You ensure participation and contribution to relevant industry association working groups related to APIs and excipients (e.g., IPEC, APIC, etc.) and/or governmental organizations.
Who you are:
- Masters or PhD degree (e.g., pharmacy, chemistry, biology)
- Leadership and project management skills, team spirit and strong communication skills
- Comprehensive expertise in regulatory affairs of APIs/excipients (ASMF/DMF regulations, China excipient registrations)
- Experience with regulatory and quality requirements for pharmaceutical starting materials, well versed with relevant GMP requirements for APIs and excipients,
- Prior experience with electronic regulatory data management system like Veeva and regulatory certification will be added advantage
- Proficient in English and German language
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of “fully vaccinated” assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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