CH Regulatory Affairs Senior Manager

il y a 2 semaines


Machelen, Belgique Bayer Temps plein

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Within Bayer, we’re changing the way we work— for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here CH Regulatory Affairs Senior Manager  As a Regulatory Affairs Senior Manager, you are responsible for the management of the assigned local portfolio including new and existing marketing authorizations for Benelux (BE, NL, LU) and products in other categories (cosmetics, medical devices and food supplement). As part of the respective cluster category team contribute to the local business growth in alignment with the overall commercial strategy providing guidance and strategic advice to processes as well as issues and risks.  YOUR TASKS AND RESPONSIBILITIES Represent Regulatory in the BNL management team. Contribute to the business growth and sustainability by managing regulatory activities and processes for the assigned brands and product categories and in line with the overall cluster and regional strategy (this includes life-cycle management as well as new product development-related activities) as well as by coaching the regulatory team across the BNL cluster. Develop, support and implement regulatory strategy and activities, tailored to the special needs of BNL countries and – if applicable/relevant – for the sub-region or region EMEA. Collaborate within the country/cluster/regional organization and provide Regulatory strategies to resolve product-related issue and risk management activities for the assigned product categories and brands. Represent BCH as competent, reliable partner to the local Health Authorities in all regulatory matters and coaches the cluster RA staff in doing so. Proactive shapes the regulatory environment in BNL cluster. May serve as Bayer representative to local trade association regulatory committees. Provides regulatory intelligence: identify current and emerging national and regional regulations, which impact the product development and/or marketing processes and ensures appropriate contribution and communication with all involved areas. Bayer Consumer Health division is active in marketing and sales of non-prescription products, both online and offline available at (online) pharmacies, para-pharmacies, drugstores and supermarkets. With brands as Supradyn, Bepanthen, Canestene and Rennie, we have a leading role in the self-care market. Our mission is to enable our customers to take accountability of their own and their families wellbeing and not letting minor health problems stand in the way of a carefree day. Do you want to contribute to our mission and make a difference for millions of people every single day? WHO YOU ARE Scientific degree (i.e. PhD, PharmD, or equivalent) Proven track records in Consumer Health Regulatory Affairs or related positions – at least 5 years in the pharmaceutical industry (mainly in Regulatory Consumer Health) Experience in working cross-functionally and with teams across multiple countries Demonstrated ability to work in regulatory capacity supporting business objectives while ensuring appropriate governance Strategic thinking and business acumen with a focus on consumer  Excellent communication skills, able to explain complex scientific topics in an understandable way and clearly associate with business case  Fluent in Dutch, French and English WHAT BAYER OFFERS YOU As a modern employer, we take care of our employees and help them find a balance between career development opportunities and personal life planning. We offer our employees a wide range of career prospects, a modern working environment and competitive compensation. Bayer employees benefit from great employment conditions, such as:  An excellent competitive salary Vacation allowance, meal vouchers, year-end premium and bonus (based on company results)  Company car, laptop and smartphone In this position you have the choice to work in a hybrid setting, working 2 days or more in the office and the other days from home. If you work from home, Bayer will provide the necessary tools and a monthly internet allowance.  34 days of leave (20 legal days, 12 work time reduction days and 2 Bayer days) Group insurance which contains a defined contribution pension plan, life insurance and disability plan, hospitalization insurance, travel insurance Bicycle lease plan An inspiring working environment with professional and committed colleagues A successful innovative organization with international career possibilities Challenges and possibilities to learn and to develop Be innovative, be Bayer. We shape the future of everyday health, patient care and agriculture. Together, we can advance health and nutrition for all. Guided by our purpose ‘science for a better life’, rooted in our DSO approach and steered by the organization’s strategy, we reach for our ambitious vision. Help bring this vision to life: Health for all, hunger for none. INTERESTED IN THIS VACANCY? Are you looking for a new challenge? Apply online by sending us your resume and cover letter (in 1 document). Do you have a question or do you want to learn more about the position? You can always contact Katrien Mertens via 0032 495541019 or katrien.mertens.ext@bayer.com. What can you expect? The application process consists of a phone screening, a personality questionnaire and reasoning test and an interview with the recruiter and hiring manager.Do you want to know more about what our people do at Bayer? Check via and follow us via #TeamBayerBenelux We do not accept any unsolicited applications and agencies. #LI-BNL


  • PMCF specialist

    il y a 2 semaines


    Machelen, Belgique Arcadis Temps plein

    Als PMCF Specialist speel je een sleutelrol in het waarborgen van de veiligheid en prestaties van onze medische hulpmiddelen na marktintroductie. Je bent verantwoordelijk voor het opstellen, onderhouden en coördineren van PMCF-documentatie en ondersteunt de klinische evaluatie en post-market surveillance processen volgens de EU Medical Device Regulation...

  • PMCF specialist

    il y a 2 semaines


    1830 Machelen, Belgique Arcadis Temps plein

    Als PMCF Specialist speel je een sleutelrol in het waarborgen van de veiligheid en prestaties van onze medische hulpmiddelen na marktintroductie. Je bent verantwoordelijk voor het opstellen, onderhouden en coördineren van PMCF-documentatie en ondersteunt de klinische evaluatie en post-market surveillance processen volgens de EU Medical Device Regulation...

  • PMCF specialist

    il y a 2 semaines


    1830 Machelen, Belgique Arcadis Temps plein

    Als PMCF Specialist speel je een sleutelrol in het waarborgen van de veiligheid en prestaties van onze medische hulpmiddelen na marktintroductie. Je bent verantwoordelijk voor het opstellen, onderhouden en coördineren van PMCF-documentatie en ondersteunt de klinische evaluatie en post-market surveillance processen volgens de EU Medical Device Regulation...

  • Head of Legal

    il y a 1 semaine


    Machelen, Belgique ManpowerGroup Belgium Temps plein

    Ready to shape the legal backbone of a people-driven organization?At ManpowerGroup, legal expertise is about more than protecting the business, it enables smart decisions and sustainable growth. As Head of Legal, you will be a trusted advisor to leadership, overseeing all legal affairs within the country and ensuring our organization operates ethically,...

  • Head of Legal

    il y a 1 semaine


    Machelen, Belgique ManpowerGroup Belgium Temps plein

    Ready to shape the legal backbone of a people-driven organization?At ManpowerGroup, legal expertise is about more than protecting the business, it enables smart decisions and sustainable growth. As Head of Legal, you will be a trusted advisor to leadership, overseeing all legal affairs within the country and ensuring our organization operates ethically,...

  • Head of Legal

    il y a 1 semaine


    Machelen, Belgique ManpowerGroup Belgium Temps plein

    Ready to shape the legal backbone of a people-driven organization?At ManpowerGroup, legal expertise is about more than protecting the business, it enables smart decisions and sustainable growth. As Head of Legal, you will be a trusted advisor to leadership, overseeing all legal affairs within the country and ensuring our organization operates ethically,...

  • Head of Legal

    il y a 1 semaine


    Machelen, Belgique ManpowerGroup Belgium Temps plein

    Ready to shape the legal backbone of a people-driven organization? At ManpowerGroup, legal expertise is about more than protecting the business, it enables smart decisions and sustainable growth. As Head of Legal, you will be a trusted advisor to leadership, overseeing all legal affairs within the country and ensuring our organization operates ethically,...


  • 1830 Machelen, Belgique ManpowerGroup Belgium Temps plein

    As Head of Legal, you will be a trusted advisor to leadership, overseeing all legal affairs within the country and ensuring our organization operates ethically, compliantly, and strategically. You will lead the legal function, partner closely with business and support teams, and collaborate with group stakeholders in a dynamic, international environment....

  • Head of Legal

    il y a 1 semaine


    1830 Machelen, Belgique ManpowerGroup Belgium Temps plein

    Ready to shape the legal backbone of a people-driven organization? At ManpowerGroup, legal expertise is about more than protecting the business, it enables smart decisions and sustainable growth. As Head of Legal, you will be a trusted advisor to leadership, overseeing all legal affairs within the country and ensuring our organization operates ethically,...

  • Senior Client Manager

    il y a 2 semaines


    Machelen, Belgique NTT DATA Temps plein

    Job Description Make an impact with NTT DATAJoin a company that is pushing the boundaries of what is possible. We are renowned for our technical excellence and leading innovations, and for making a difference to our clients and society. Our workplace embraces diversity and inclusion – it’s a place where you can grow, belong and thrive.Your day at NTT...