Regulatory Affairs Manager, Personal Health Care

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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 technical skills an entrepreneurial spirit, real passion for winning, and the ability to build reciprocal relationships?

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

Regulatory Affairs is essential to enabling and maintaining Pharmaceutical and Health Care business, including Medical Devices, Food and Vitamins and cosmetics. 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, acting as a key technical expert and regulatory consultant, supporting the current portfolio and new initiatives, implementing the newest systems and regulatory platforms in Belgium, interfacing with external stakeholders and strategic partners.

YOUR CONTRIBUTION TO P&G’S SUCCESS:

• Manage all regulatory activities needed to obtain Marketing Authorizations (MAs) and other authorizations for all medical and non-medical products (e.g., medical devices, food supplements, cosmetics) within the Benelux region.

• Regulatory strategy: contribute to the development of the regulatory strategy by sharing the local point of view regarding all new initiatives (e.g. registrations of new products) and maintenance activities (e.g. variations) and ensure submissions are done in due 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/EU regulatory requirements.

• Ensure compliance of the local P&G Health product portfolio to applicable regulations, guidelines and internal standards. Especially focusing on pharmaceuticals, food supplements, cosmetics and medical devices.

• Regulatory Intelligence: advise the broader organization – both local and global stakeholders – on potential risks emerging from changing local legislation and act accordingly.

• Strong interaction with the commercial organization. To advise organization of potential regulatory risks and recommend compliant actions.

• Interaction with local Boards of Health (BoHs) and Trade Associations (Tas): first point of contact, including strong relationship and present the interests of the organization, gain relevant information and help shape change.

• Prepare and submit all Pricing applications.

• Close collaboration with Quality Assurance (QA) by: co-operating during internal audits, leading/attending inspections and executing CAPA plans, ensuring the Corporate Change Control System is kept up to date.

• In case of a qualification of Industrial Pharmacist: work closely with Local QA manager, act as Deputy QA from external partner and act as back up Qualified Person (e.g. supervising CAPAs, local release of batches, etc.)

• In case of a qualification of Pharmacist: potentially be appointed as Responsible Person for Information and Publicity (RIP) towards the Belgian BoH - FAGG (e.g.: close interaction with commercial team on defining the strategy for promotional materials, approval all materials in corporate system, submit dossiers on promotional material to BoH, first point of contact with BoH)

Job Qualifications

YOU ARE THE RIGHT FIT IF YOU HAVE/ARE:

• Degree in Pharmacy, with a preference for Industrial Pharmacy

• Previous experience in similar roles, minimum 2 years, max 5 years

• Fluency in Dutch and French, mother-tongue or equivalent. English both written and spoken.

• Proven ability to rapidly acquire knowledge and understanding of therapeutic categories, analyze scientific and clinical data/information, translate data/information into business relevant language and messaging.

• Demonstrated managerial skills, specially having a strong track record of success as a leader or agent of change and ability to lead multiple projects. Ability to integrate technical and commercial thinking and priorities.

• Very strong communication skills.

• Exceptional collaboration and teamwork sills. Comfortable in working in a matrix organization with multiple partners, stakeholders and customers.

• Demonstrated ability to handle competing priorities effectively.

YOUR ADVANTAGES :

• A fixed contract, with an attractive compensation package;

• Competitive pay, including monthly salary, 13th month at the end of the year as well as an annual variable bonus.

• A flexible benefits plan to customize to your personal needs and kilometer allowance/public transport reduction;  

• Hospitalization plan after 6 months of employment, pension plan, life insurance plan, long term illness insurance and stock purchase plan;

• Access to Benefits at work platform: A large benefits platform with employee discounts on renowned shops and online commercial platforms as well as on leisure activities and well-known amusement parks;

• Working in an international and inclusive environment, with diverse and supporting colleagues. 

• Continuous self-development via coaching, trainings and a general Growth Mindset working environment; 

• A vibrant and modern working environment, supporting employees’ wellbeing: 

· Subsidized company restaurant; 

· On-site vibrant Café for breaks and less formal meetings; 

· On-site fitness room and possibility to join regular group sport activities; 

· Flexibility in terms of working hours and remote working for a good balance between personal needs and the job to be done.

· Employee Assistance Program: free professional counseling services, work-life resources, and mental health support.

• Supporting employees’ commute: plenty of parking facilities for both cars and bikes, shower facilities, shuttle between Heizel metro and the office, carpooling community.

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ARE YOU EXCITED ABOUT THE ROLE? DEEP DIVE INTO P&G AND CHECK THE BELOW INSIGHTFUL LINKS:

• Our hiring process consists of three main steps: 1) application, 2) online assessments and 3) interviews. Click here to get all the tips to be fully prepared.

• P&G is driven to make life better, not just within the company, but across the globe. Click here to check out how we make a meaningful impact on the world.

• We are the world’s largest consumer goods company. Click here to discover about our iconic brands.

Encouraging diversity in all its forms, P&G is committed to creating an inclusive work environment and promotes equal opportunities.

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