Manage all regulatory activities needed to acquire Marketing Authorizations (MAs) and other authorizations for all medical and non-medical products (e.g., medical devices, food supplements, cosmetics) in Poland.
Regulatory strategy: contribute to the development of the strategy by sharing the local point of view regarding all initiatives (e.g. registrations of new products) and maintenance activities (e.g. variations) and ensure submissions are done in time.
Accurate maintenance of the Corporate Database on product information and any external database (if applicable).
Review, approve and ensure full compliance of artworks.
Revision and clearance – via Corporate system – of advertising materials to ensure full compliance with local requirements.
Ensure compliance of the local P&G Health product portfolio to applicable regulations, guidelines and internal standards. .
Regulatory Intelligence: advise the broader organization – both local and global stakeholders.
Strong interaction with the commercial organization. To advise organization of potential regulatory risks and recommend actions.
Interaction with local Boards of Health (BoHs) and Trade Associations (Tas): first point of contact, including positive relationship and present the interests of the organization, gain relevant information and help craft change.
Prepare and submit all Pricing applications.
Close collaboration with Quality Assurance (QA) by: co-operating during internal audits, leading/attending inspections and implementing CAPA plans, ensuring the Corporate Change Control System is kept up to date.
Wymagania
Minimum a MSc degree or equivalent experience in life- or natural science (e.g. medical/veterinary doctor, pharmacy, biology, chemistry, bioengineer etc.).
Proficiency in Polish and English.
Proven track record to rapidly acquire knowledge and understanding of therapeutic categories, analyze scientific and clinical data, translate information into business relevant language and messaging.
Strong communication skills.
Outstanding collaboration and teamwork sills.
Comfortable in working in a matrix organization with multiple partners, stakeholders and customers.
Demonstrated ability to handle competing priorities effectively.
Oferujemy
Competitive starting salary and benefits program (private health care, life insurance, PG stock options, saving plans, lunch subsidy, sport cards, in-office fitness center, company car and parking).
Career development in a multinational company with a friendly team and high standards.
Regular salary increases and possible promotions - all in line with your results and performance.
P&G Vibrant Living programs.
Regular salary increases and possible promotions - all in line with your results and performance.
