Zusammenfassung
About the Role
Major accountabilities:
- Prepare and submit post-approval changes (CMC variations) to HA, including dossier review and strategy definition.
- Conduct regulatory evaluation of post-approval changes to assess their impact and ensure adherence to relevant guidelines and legislations.
- Collaborate with cross-functional teams to define project timelines and provide information on regulatory requirements for submissions.
- Review less complex post-approval change dossiers
- Maintain and update area databases, ensuring all information and documentation is accurate and up-to-date.
- Support in reviewing and updating labeling material and ensuring compliance with HA requirements
- Participate in meetings with minor and moderate impact at trade associations
- Provide regulatory guidance and support to cross-functional teams during the development and implementation of post-approval changes.
Minimum Requirements:
Work Experience:
- Bachelor's degree in Pharmacy or related courses.
- Prior experience working in the regulatory affairs area of Pharmaceutical Industry
- Detail-oriented and highly organized, capable of managing multiple projects simultaneously
- Excellent analytical skills with the ability to interpret and apply regulatory requirements to post-approval changes.
Languages:
- Advanced English language proficiency.
You’ll receive:
Competitive salary, annual bonus, pension scheme, life insurance, 30 days annual leave, year-end recess, hybrid work model (home office 2x a week), flexible working arrangements, birthday day-off, maternity and paternity leave, subsidized dining facilities, health and dental insurance, employee recognition scheme, free parking lot (Santo Amaro and Cambe), Gympass, Space Energized for Life, gym (Santo Amaro) and virtual self-development tools.
Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
