Job Location

Warsaw

Job Description

Have you ever thought about applying your technical knowledge to contribute to build Pharmaceutical and Health Care business? Are you a leader who possesses in addition to skills and spirit, real passion for winning, and the ability to build relationships?

If so, the position of Regulatory Affairs Manager at P&G PHC in Warsaw is the perfect role for you!

Regulatory Affairs is crucial to enabling and maintaining Pharmaceutical and Health Care business. As a function, we ensure that all our current and new products are fully compliant to local and international requirements as well as to high internal Company standards. You will be part of multifunctional team, supporting the current portfolio and new initiatives, implementing the newest systems and regulatory platforms in Poland, collaborating with external stakeholders and strategic partners.

YOUR CONTRIBUTION TO P&G’S SUCCESS:

• 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.

Job Qualifications

• 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.

What we Offer:

• 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.

Please apply by submitting your CV in English!

P&G’s Day 1 starts with you doing something that matters – making an impact on the world, P&G brands, and your career. You’ll be at the core of breakthrough innovations, be given exciting assignments, lead initiatives, and take ownership and responsibility. And you will do this in creative workspaces where new ideas flourish. All the while, you’ll receive world-class training to help you become a leader in your field. And it’s not just about what you’ll do, but how we will make you feel: welcomed, valued, purposeful, challenged, heard, and inspired.

We commit to provide you with equal opportunities in employment. We value diversity, and we do not discriminate on the basis of race, religion, colour, national origin, gender, gender identity, sexual orientation, age, marital status, veteran status, or disability status….

In case of any questions, you can get to know us better here: https://www.pgcareers.com/

Job Schedule

Full time

Job Number

R000119034

Job Segmentation

Experienced Professionals (Job Segmentation)