Regulatory CMC Facilitator (d/f/m)

331966BR
Nov 26, 2021
Germany

Job Description

150+. We deliver our drug products including major brands to more than 150 countries worldwide. Would you like to be part of our dynamic team?
You have an important role in the coordination of Regulatory CMC related activities over the Product life cycle ranging from Product Launch & Transfers, Post approval change control, steering of remediation activities to divestment and due diligence, to ensure compliant drug product supply to the markets in-line with the registration and support new registrations.

Your responsibilities:
Your responsibilities include, but not limited to:

• In your role, you will support global CMC activities for product Launches, Transfers and other submissions. Lead and coordinate for the manufacturing sites global and local products the timely and consistent review of registration documentation in teamwork with experts on site. Focus on correct data in-line with the sites technical documentation. Scientific sound documentation will support successful submissions.

• You will coordinate the preparation of CMC responses - in reply to Health Authority Questions from regulators worldwide - in a timely manner. This includes dealing with key regulatory bodies such as US FDA, EMA/EU, and Health Authorities of Japan, China and Brazil, but is not limited to them and in fact really worldwide. Responses are elaborated working together in global teams, in collaborative partnership with Global Regulatory CMC, and with the related Country Organizations (CO) considering county specific requirements; while the technical content is provided working cross functional with the subject matter experts on the site. Your impact may contributes to the fast approval of initial marketing authorizations and of variations.

• You have an important role in evaluating regulatory requirements and providing strategic regulatory guidance for projects, give oversight and review the adequate handling and implementation of change requests in order to ensure Regulatory Compliance. Ensure the Regulatory Commitments to Health Authorities are submitted in time.

• In your role you will act as single point of contact and advisor for regulatory information, maintain the knowledge of the global dossier for the products of the site (CTD module 3). Provide regulatory support during Health Authority Inspections on site, which is including pre approval inspections by FDA.

• While keeping track with regulatory knowledge and new regulatory requirements, you will share lessons learned and coordinate CMC related Training for the sites personnel.

Diversity & Inclusion / EEO

Novartis ist bestrebt, ein hervorragendes, integratives Arbeitsumfeld und ein vielfältiges Team aufzubauen, das die Patienten und Gemeinschaften, denen wir dienen, repräsentiert.

Minimum Requirements

What you’ll bring to the role:
• Degree in science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Fluent in English working in global teams with global documentation, fluent in German for the technical documentation of the site and remaining local product dossiers
• Good communication and negotiation skills, very detail orientated, analytical and problem-solving skills
• We are looking for a Self-motivated personality and Cross functional team player
• Experience in regulatory CMC environment is of advantage, incl. knowledge of regulations, submission and approval processes for new products and product life cycle management.
• Experience working in a manufacturing site is required
• Good knowledge of MS Office and other standard applications

Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks. And where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO QUALITY
Germany
Wehr
Vollzeit
Unbefristet
Nein
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331966BR

Regulatory CMC Facilitator (d/f/m)

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