Associate Manager Regulatory Cmc

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.

**Position Title: Associate Manager Regulatory CMC(Biotech)**
**Your role**:
You will be responsible for driving and supporting all global CMC submission activities (incl. planning, authoring, reviewing, coordination, submission) for commercial biotech products and projects worldwide. In this role you will develop the relevant global regulatory CMC life cycle strategy and represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnership with stakeholders such as technical CMC-, quality-, supply
- and regulatory affairs functions.

This encompasses the responsibility for authoring and reviewing high-quality CMC documentation for Health Authority submissions, while ensuring technical congruence and regulatory compliance. Beyond this you will identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. In addition, you will perform regulatory assessments for changes.

**Who you are**:

- University degree in Life Sciences such as Biochemistry or Biotechnology (minimum MSc or equivalent degree)
- Minimum of 1 year of pharmaceutical industry experience in either CMC regulatory compliance and/or a CMC technical role (e.g. in regulatory affairs, quality control, analytical development or manufacturing / process development)
- Thorough understanding of biotechnological processes such as upstream/downstream processing
- Experience in preparation and management of regulatory CMC documentation and the management of the regulatory life-cycle management (e.g. annual reports, renewals, variations).
- Practical Experience with Regulatory Information Management Systems and Trackwise
- Sound understanding and or relevant global pharmaceutical legislation
- Good project, time management and planning skills
- Ability to work in teams
- Attention to details
- 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)

**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

Job Requisition ID: 242129

Location: Aubonne

Career Level: B - Recent University Graduate(

Working time model:
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