Regulatory&Medical Affairs Head

ABOUT US

STADA is leading manufacturer of high-quality pharmaceuticals. With a long-standing heritage rooted in pharmacies, we are perceived as a reliable and trustworthy partner for more than 120 years. With our products we help people protect and regain a dignified and able life. With our proven Generics, we ensure that everyday health remains affordable.

STADA Ukraine is looking for Regulatory&Medical Affairs Head who is responsible for leading and managing the Regulatory, Medical and Pharmacovigilance units in order to guarantee the demanding products registrations, medical support for business, patients support on time, complying with the legal requirements.

RESPONSIBILITIES WILL INCLUDE:

• Develops and implements Regulatory Affairs, Medical Affairs, Pharmacovigilance strategies and policies according to STADA vision and guidelines.
• Ensure the overall Regulatory Affairs, Medical Affairs and Pharmacovigilance processes are integrated, implemented and works effectively.
• Ensures consistent guidance and interpretation of regulations, standards, and regulatory intelligence and development planning, registration planning, and impact assessments.
• Ensure compliance to all relevant national and international guidelines and regulations.
• Collaborate with cross-functional teams providing medical insight and scientific expertise; participating in key strategic decisions.
• Develop of the relationsth representatives of governmental agencies, medical academic and scientific institutions, competent agencies, charities and patient organizations.
• Monitor local legislation and competitive environment changes, promoting awareness of regulatory and medical requirements, registration status changes within the company; influence legal landscape via local networking.
• Support continuous improvement initiatives and implement new technologies.
• Participate as a full member of the Country Leadership Team, helping to define business strategy and objectives.
• Lead the Regulatory&Medical Affairs Department ensuring availability of competent, high performing people and competence in expert area.

WE EXPECT FROM YOU:

• 10+ years of experience in relevant positions in the pharmaceutical industry. Minimum 3 years with people in charge and business objectives.
• Degree in medical science, pharmaceutical or similar.
• Proven experience driving changes and compliance in an organization.
• Strong knowledge of local regulatory requirements.
• Excellent verbal and written communication skills.
• Ability to work in a fast-paced, dynamic environment.
• Possess an understanding of both the pharmaceutical and healthcare industries.
• Proficient organizational skills with the ability to manage multiple complex projects and tasks.
• Ability to inculcate culture of growth and continuous improvement.
• Fluent English.

WE WOULD LIKE TO OFFER YOU:

• Competitive remuneration and benefits program.
• Experience in value driven international company.
• Opportunities for professional growth.

Read more about STADA:

https://www.stada.com/

https://www.linkedin.com/company/stada/mycompany/