Associate Director, Regulatory Affairs CMC

Job Description Summary

#LI-Hybrid
Location: Schaftenau, Austria

Novartis are seeking an Associate Director to lead regulatory activities related to Chemistry, Manufacturing and Controls (CMC). The role involves preparing and publishing CMC regulatory documentation for Health Authority submissions, as well as interacting with Health Authorities on CMC queries to support new product launches and post‑marketing activities.

 

Job Description

Key Responsibilities:

• Formulate, lead and drive global CMC regulatory strategy for projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance.

• Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions.

• 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.

• Author and/or review high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.

• Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnerships with stakeholders

• Initiate and lead Health Authority interactions and negotiations: setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Establish and maintain a single point of contact with FDA.

• Provide strategic advice and direction within the department and cross-functionally through specialized assignments.

Essential Requirements:

• Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent.

• Minimum 8 years regulatory experience and/or pharmaceutical industry experience.

• Substantial knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements.

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

Benefits & Rewards:

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. 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 €78,383.90 /year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications, and individual competencies.

Commitment to Diversity and Inclusion / EEO:

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

Accessibility and Accommodation:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

 

Skills Desired