Regulatory CMC Associate Manager

Regulatory CMC Associate Manager (d/f/m) - temporary for 2 years

Kundl (Sandoz) | Full time

Job Description Summary

As a member of our Global Regulatory Affairs CMC team, your role would be to support timely preparation of high-quality CMC regulatory documentation and to contribute to global regulatory submissions and strategies for biosimilar projects.

Job Description

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!

As a member of our Global Regulatory Affairs CMC Team, your role would be to support timely preparation of high-quality CMC (Chemistry, Manufacturing and Control) regulatory documentation and to contribute to global regulatory submissions and strategies for biosimilar projects.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Author high-quality global CMC documentation for Health Authority submission throughout the product lifecycle of biosimilar products.

• Apply agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.

• 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.

• Coordinate, collect, store source documentation needed for direct submission to Health Authorities.

• Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.

What you’ll bring to the role:

Essential Requirements:

• Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent with oral and written fluency in English.

• Interest in regulatory and/or in the pharmaceutical industry.

• Interest for regulations, guidelines and product life cycle maintenance.

• Knowledge of chemistry/biotechnology, analytics or pharmaceutical technology.

• Ability to critically evaluate data from a broad range of scientific disciplines.

• Good oral and written communication skills with a collaborative and patient-focused mindset

• Ability to work successfully with global project teams and prioritize activities considering timelines and workload.

• Well-developed planning, organizational, negotiation, problem solving and interpersonal skills.

• Computer/IT systems literacy.

Please note, that this position is based in Kundl (Austria) and on-site presence for at least 50% is required. We offer a 2-year fixed term contract role with the possibility to be transferred into a permanent position.

Your benefits:

• Attractive salary with incentive program

• Modern company pension scheme

• Flexible working hours / home-office depending on the position

• 14 weeks of paid parental leave

• Additional days off (bridge-days) for more leisure time

• Subsidized meals in our canteen

• Sustainable mobility in the form of company transportation, shift buses and car sharing

• Company day-care and summer camps for children

• Wellbeing & mental health offers

• Learning and development options for your personal and professional growth

• Worldwide career opportunities

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 58.199,96/year (on a full-time basis).

We also offer a potential market-oriented excess payment in line with your experience and qualifications.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.

Skills Desired

Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance