Head of Regulatory Affairs Department

750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks. And where you're surrounded by people who share your determination to tackle the world's toughest medical challenges. We are now looking for Head of Regulatory Affairs Department to further develop and sustain our activity in Ukraine.

Your Responsibilities: 

• Develop local Regulatory Affairs (RA) strategy in line with the global strategy, local insights and market conditions, and secure implementation of planned RA activities.
• Develop strategic engagement plan(s) for local RA activities and ensure timely execution of planned RA activities in an efficient and compliant way.
• Lead RA activities, including preparing and submitting regulatory filings, managing audits, and ensuring compliance with applicable laws and regulations.
• Ensure regulatory compliance for a sustainable product’s life-cycle management: safety label change, labeling, CMC, RMPs, PSUR and other life-cycle support to be performed in accordance with local regulations and relevant Novartis SOPs.  
• Provide leadership in cooperation with business units, commit to team goals, and effectively communicate regulatory position. Lead cross-functional project teams. 
• Contribute to product’s availability on market through close interaction with QA/ Supply Chain departments.
• Support of regulatory intelligence (legislation and trend review) and continuous improvement of submission process, templates and knowledge transfer within project teams.
• Monitor impact of changing regulations and update internal stakeholders to effectively assess and report on the business to define engagement requirements.
• Anticipate regulatory obstacles and emerging issues and develop solutions with other members of regulatory and related teams.
• Review protocols/ reports/ materials in terms of compliance with regulatory submissions and applicable regulations.
• Lead and develop high-performing RA teams, providing mentorship, training, and guidance to ensure individual and team success.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors and vendors.
• Build effective working relationship with health/ regulatory authorities.
• Comply to regulations, other regulatory requirements for region, Company policies, operating procedures, processes, and task assignments. 

What you'll bring to the role: 

• 5+ year of similar experience in Regulatory Affairs in pharmaceutical market.
• Knowledge of regulatory requirements and industry guidelines related to Regulatory Affairs.
• Proven record of agile, independent problem-solving skills, combined with excellent communication and change management skills.
• Strong analytical skills, with the ability to identify and address complex business needs.
• Confidence in advising, constructively challenging and achieving targets.
• Demonstrated ability to collaborate with and achieve actionable results through others, the ability to build strong, sustainable relationships and interact within all levels of the organization.
• Strong sense of ownership and high commitment to take responsibility and get things done.
• Strong interpersonal skills particularly motivational, negotiation, listening, and conflict management skills, demonstrated by ability to lead teams.
• Excellent English written and oral communication skills.

You'll receive:

Opportunity to work in an international innovative company, professional and career development opportunities, flexible working arrangements, annual bonus, medical and life insurance, employee recognition program.

Find out more about Sandoz Ukraine: https://www.sandoz.ua/

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