Regulatory Affairs Manager

• Overall responsibility to SÚKL for Marketing Authorization Applications, post-approval maintenance of Novartis products and/or Marketing Authorization withdrawals within pre-defined time frame.
• Responsible for proper and in-time reporting of changes in regulatory rules in CR.
• Ensure correct and approved package materials in local language within pre-defined time frame.
• Assists in production of package materials in local language.
• Support actively and cooperate closely with product management in efforts to achieve optimal categorization and positive listings of our products.
• Keeping good professional contacts with key personnel at SÚKL.
• Cooperate with other colleagues in other departments to ensure the efficient use of company resources for the overall success of the Sector.
• Responsible for on time reporting of spontaneous adverse events (AE) reports and technical complaints for all Novartis products.
• Performs special assignments as discussed with the DRA Head.
• Timely and correct submissions of renewals, variations and new applications.
• Timely and correct submissions of package layouts for medical products.
• Ensure entries to local DRA database are complete and up to date.

Experience:

• Educated to Degree level or preferably Pharmacist or Medical Doctor
• 1-2 years’ experience of Regulatory Affairs or Pharmacovigilance
• Native Czech speaker with fluency in English
• Drug Regulatory Affairs: Understanding of registration processes and issues, knowledge of related local regulations, laws, legal directives and requirements.
• Administration and Self-organization: Systematic, organized, accurate and thoughtful work style, dealing with extensive amounts of documentation.
• Commercial Proficiency: Understanding general competitive environment of the area and relevant business, terminology and concepts.
• Operational Excellence: Implementing appropriate templates and style guidelines correctly using optimized processes to meet regulatory standards and marketing/commercial needs.

You’ll receive:

Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 5-week holiday per year; (1 week above the Labour Law requirement) ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Benefit Plus Cafeteria in the amount of 12,500 CZK per year; Meal vouchers in amount of 105 CZK for each working day (full tax covered by company); Car Allowance; MultiSport Card, Employee Share Purchase Plan. Find out more about Novartis Business Services: https://www.novartis.cz/

Why Novartis:

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

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

Accessibility and accommodation:

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to <di.cz@novartis.com> and let us know the nature of your request and your contact information. Please include the job requisition number in your message.