Sr Manager Regulatory CMC Small Molecule Development - NCE & ADC (m/f)

A career at our company is an ongoing journey of discovery: our 58,000 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.

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 lead and drive regulatory CMCactivities. You develop and are accountable for the global regulatory CMC and CMC dossier strategy. Furthermore, in being responsible for leading the content of the CMC dossier you act as liaison between Global Regulatory Affairs and CMC technical functions for new chemical entities from clinical phase I, II, III, first registration until launch (incl. phase IV) and Antibody Drug Conjugates (ADCs) (ADC DS, ADC DP, drug linker) until end of clinical phase II and for the drug linker until launch. This encompasses the accountability for strategic planning, authoring, review and approval of all regulatory relevant quality documents (e.g. MAA/NDA, IMPD/IND, Scientific Advice documentation, Answer to Objections). You are accountable for evaluation, interpretation and translation of the country regulatory requirements into CMC/technical requirements and to provide them proactively as prospective advice to the CMC functions/laboratory heads in analytical development, formulation development, drug substance development, and others e.g. non-clinical development. Furthermore, you are accountable for CMC topics in the context of Health Authority interactions/meetings. In addition, you contribute to risk and gap assessments and perform an expert assessment of in-and out licensing projects for business development (Due Diligence).

You are a permanent member in the Global Regulatory Strategy team, the CMC project team and other international and interdisciplinary working groups.

Who you are:

• University degree in pharmacy or chemistry or life science, Ph.D. beneficial
• Minimum of 5 years of pharmaceutical industry experience, with at least 3 years of global CMC regulatory experience
• Excellent communication skills including interaction with all levels of the organization
• Broad knowledge of regulatory CMC requirements (EU, US, ICH and other relevant guidelines), IMPD/IND requirements and EU as well as US Pharmacopoeias and GMP regulations
• Experience in Health Authority interactions
• Excellent written and spoken communication skills in Englis
  

What we offer:With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Job Requisition ID: 226592

Location: Aubonne

Career Level: D - Professional (4-9 years)

Working time model: full-time, part-time possible

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 Disclosure
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.

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.

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