Regulatory Affairs Manager

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. 

Johnson & Johnson is looking for a Regulatory Affairs Manager based in Moscow

Main Responsibilities:

• Provides strategic planning and leadership of the Regulatory Affairs team (Surgery) – 8 employees (direct and matrix reporting).
• Ensures development and timely execution of the regulatory strategies for innovative products to support the fastest entrance to the markets across RU&CIS Cluster.
• Ensures development and timely execution of the regulatory strategies for legacy portfolio across RU&CIS Cluster.
• Provides strategic input into regulatory development programs, lifecycle management, and compliance activities.
• Supports cross-functional teams and projects with regulatory insights.
• Supports shaping of regulatory environment, advocacy and intelligence activities.
• Be the face of the organization to regulators, participates in appropriate forums and conveys the Company’s point of view on all relevant matters; represents the company in industrial associations if needed.
• Financial budget planning for Surgery subdivision. Deliver on RA BP, fiscal discipline and identify financial efficiency opportunities.
• Engagement and support of the x-functional communications with external partners – Government Bodies, Distributors, Clinics, etc.
• Support and following of the policies associated with QMS system of JnJ (NCs, CAPAs, etc.)
• Active engagement into external and internal audits from RA standpoint

Requirements:

• Graduate in pharmacy/ biology/ chemistry/ engineering or medicine is preferable
• 3 years+ experience in Regulatory Affairs for medical devices
• Deep and strong expertise in regulation of medical devices registration for RU&CIS countries (incl. EAEU) and international regulation (e.g. FDA, MDR etc.)
• Team management (5+ employees) experience 1+ years (in direct subordination and/ or project team management, including remote teams and management of 3rd parties)
• Project management skills
• English (verbal and written) – Upper-Intermediate+
• Expertise in general business processes execution
• Goal oriented, responsible, dedicated
• Excellent communication and negotiation skills, good in listening, good problem-solving and influential skills