GDD Regulatory Affairs Manager IAPM (d/f/m)

Oct 04, 2021

Job Description

2 bn people in the world have no access to basic medicines and healthcare and about 100 mn people are impoverished by medical expenses each year. We in IAPM aim to improve access to healthcare for low-income & underserved populations globally. As part of the RA IAPM team, you will be responsible for registering and maintaining products in dedicated countries to make our high-quality medicines available to these patients.

Your responsibilities:
The Global Drug Development Regulatory Affairs Manager IAPM (Integrated Access Programs and Markets) is responsible for the coordination of regulatory activities in dedicated IAPM countries (from planning to execution) as well as for the creation and maintenance of artworks for all global Sandoz products under IAPM responsibility.

Your responsibilities include, but not limited to:
• Act as main point of contact of IAPM regulatory activities in selected IAPM countries
• Provide and coordinate cross-functional planning and tracking of submissions considering time, cost, and commercial strategy
• Manage regulatory activities to ensure launch readiness
• Act as a solution-oriented interface between IAPM team and Regulatory centres
• Play key role as business partner to project team to support Portfolio Extension and Business Growth in low-middle-income countries
• Monitor new country requirements and inform all stakeholders regularly about any updates
• Ensure proper documents’ archiving
• Provide monthly report about RA IAPM achievements, performance, challenges for dedicated colleagues in Global Health IAPM
• Artwork (AW) coordination for dedicated Sandoz products under IAPM global responsibilities (common SKUs and defined countries)
• Provide guidance on NSB Design Manuals for Sandoz and Pharma
• Creation of artworks for submission/launch purposes for common SKUs in alignment with global IAPM RA, RCC, Medical, Value Change Management, and packaging sites
• Maintenance of artworks and IAPM artwork database and relevant tracking tools

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Academic degree in sciences (e.g., Pharmacy, Chemistry, Biology, Biochemistry)
• Fluent English required (oral and written), Good skills in local language of site desired (German, oral); additional languages advantageous (e.g., Spanish, French)
• min 3-4 years of experience in regulatory affairs and project management, preferably experience in emerging markets

Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, 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:
Holzkirchen (near Munich)
Research & Development
Full Time
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GDD Regulatory Affairs Manager IAPM (d/f/m)

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