About the Company
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. We discover and develop innovative medicines, gene therapies, and digital health solutions. With a rich heritage of scientific innovation and a commitment to transforming medicine, we strive to improve and extend people’s lives through breakthrough science and technology.
Job Description
We are seeking a highly motivated and detail-oriented Drug Safety Chemist with a strong focus on Regulatory Affairs to join our dynamic team. This is a fully remote position, offering the flexibility to work from home while collaborating with a global team. The successful candidate will play a critical role in ensuring the safety of our pharmaceutical products by managing and interpreting chemical and toxicological data in alignment with global regulatory requirements. You will be instrumental in the preparation and submission of regulatory documents, contributing directly to the lifecycle management of our innovative therapies.
Key Responsibilities
- Perform in-depth analysis of chemical and toxicological data related to drug safety.
- Contribute to the preparation, review, and submission of regulatory documents (e.g., INDs, NDAs, MAAs) focusing on chemistry, manufacturing, and controls (CMC) aspects relevant to safety.
- Monitor global regulatory intelligence for changes impacting drug safety and CMC aspects.
- Collaborate with cross-functional teams, including R&D, Clinical Operations, and Quality Assurance, to ensure comprehensive safety assessments.
- Develop and maintain internal standard operating procedures (SOPs) related to drug safety and regulatory submissions.
- Participate in regulatory agency interactions and support responses to questions.
- Conduct literature reviews and gather scientific information to support safety evaluations.
- Ensure compliance with all applicable global regulations and internal policies.
Required Skills
- PhD or Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific field.
- Minimum 3 years of experience in drug safety, pharmacovigilance, or regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong understanding of chemical principles, toxicology, and drug development processes.
- Proficiency in interpreting and summarizing complex scientific data.
- Familiarity with global regulatory guidelines (e.g., FDA, EMA, ICH) related to drug safety and CMC.
- Excellent written and verbal communication skills in English.
- Ability to work independently and collaboratively in a remote team environment.
- Strong organizational skills and attention to detail.
Preferred Qualifications
- Experience with electronic document management systems for regulatory submissions.
- Knowledge of GxP regulations (GLP, GCP, GMP) as they apply to drug safety.
- Experience in risk assessment and mitigation strategies for pharmaceutical products.
- Certifications in Regulatory Affairs (e.g., RAC).
Perks & Benefits
- Comprehensive health, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Generous paid time off and holidays.
- Flexible work-from-home options and work-life balance initiatives.
- Opportunities for professional development and continuing education.
- Employee assistance program and wellness initiatives.
- Access to innovative research and development projects.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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