Holding company Johnson & Johnson which engages in the research and development, manufacture and sale of products in the health care field is currently looking for a Regulatory Affairs Director.
Main Responsibilities:
Lead a regulatory department of approximately 20 people to ensure that new products are launched, and existing products maintained, in support of Russia, Ukraine & CIS business plans.
Contribute to development of pipeline strategies to ensure Russia, Ukraine & CIS needs are met – identifying and communicating data needs and registration timings
Keep up-to-date on the Company’s products and pipeline to identify opportunities for local markets, and communicate registration requirements
Develop regulatory strategy for Russia, Ukraine & CIS countries to ensure balance of rapid registration timings and strong claims to enable products to win in market
Keep abreast of emerging legislation related to medicines and cosmetics, and highlight potential opportunities and impact to the business
Represent RA function at the local Board level and be a source of business ideas
External representation of J&J Consumer Health with Health Authorities and Trade Associations as needed
Grow and develop talent within the regulatory organization.
Develop and implement Regulatory systems to ensure optimization of regulatory processes.
Make sure that all global systems are updated in a timely manner.
Control of databases on Department’s activities; communication of plans and achievements.
Control the compliance of products to relevant legislation requirements and global SOPs.
Be a partner to commercial organization and other intra-affiliate and intra-company divisions to make sure they receive proper regulatory support.
Ensure compliance with Company’s corporate policies, procedures and guidelines as well as with local regulations to meet statutory, quality and business requirements within the overall strategy and objectives of the Department.
Requirements:
Excellent communication and negotiating skills.
Broad knowledge of local Regulatory environment and ideally OTC business in Russia, Ukraine & CIS.
Strong knowledge of local Regulatory Affairs requirements for medicines, experience of cosmetics also desirable.
Strong leadership experience with a track record of building and growing teams.
Team player, able to form strong partnerships with other departments.
>10y Regulatory Experience and >3 years of experience in a management role (leading of leaders), ideally in an International company within the Healthcare Industry.
Ability to undertake financial management with experience of budget setting and management.
Advanced English and Russian essential – verbal and written.
Advanced PC user (Adobe, Windows, ability to work in different electronic systems).
Minimum Education: University degree, Pharmacy/Medical or Life Sciences.
Company offers
Competitive benefit package.
Corporate car (or car allowance).
Medical and life insurance.
Corporate mobile phone.
Great opportunity for professional and career growth (including international assignments).
