CH Regulatory Affairs Senior Manager, Diegem

Bayer is an international group whose core businesses lie in the healthcare and agriculture sectors. At the intersection of chemistry and biology, Bayer helps to improve quality of life by offering products and services in human and plant health.

Tasks

• 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?

Profil

• 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