Regulatory Senior Manager - Belgium
Want to know company name or location? Company managed [?]
- Our company is one of the largest companies in the consumer health and personal care industry in Europe.
- Our company has a wide brand portfolio including top brands.
- Our company has managed to build a high performance, customer-focused organization which today is directly active in 35 countries, serving a high potential market of prescription-free, consumer-oriented health products.
- Its headquarters are based in Belgium.
- our company is currently recruiting for a Senior Regulatory Manager.
Main duties and responsibilities Fuel Growth
- Maintain a level of expertise which significantly contributes to growth in the business, within the portfolio they are accountable for (e.g. category, product type, territory, technical speciality).
- Where leading a team, leverage this team to deliver the regulatory actions needed to get products to market and keep them there with optimised positioning versus the business strategy.
- Take minimal direction from senior leaders to achieve their goals.
- Ensure our company is synonymous with world-class regulatory documentation and influencing capability, to ensure regulatory aspects are never a barrier to our commercial goals.
- Be a trusted voice in the innovation / NPD process to ensure all opportunities are optimized and we have an appropriate balance of risk vs. return within the pipeline.
- Work in close partnership with the cross functional team, being a trusted partner in NPD strategy. Work to increase external network in the regulatory community.
- For International: Support the affiliate regulatory teams to find creative ways to influence their local Competent Authorities to ensure product success.
- For Affiliate: Work with International Reg to ensure country expertise is considered in evolving regulatory strategy.
- Ensure compliance with appropriate global legislation governing Safety Surveillance, Manufacturing and Distribution of products, resulting in no interruption to flow of business or impact on company reputation.
The job holder will:
- Ensure full personal compliance with Company Codes of Conduct
- Drive the teams under his/her consultation to achieve the necessary standards of technical service, product quality, efficiency, training, documentation, quality and compliance.
- It is vital this is done in a manner which is inclusive, provides appropriate delegated authority and in a fair and consistent style so as to engender a committed team approach
- Ensure appropriate reporting through the business to enable appropriate tactical and strategic decisions to be made to protect, enhance and develop the business
- Spend sufficient time at the sites relevant to their role, to be able to develop and maintain understanding of the processes and people, communications/relationships
- Have a thorough understanding of the legal and technical framework within which we operate.
- The job holder will be representing the company externally and, where appropriate, will contribute to the company’s influence and reaction to media, customer, competitor communications in conjunction with the Executive Team and/or company colleagues
Minimum Qualification and Experience:
- Min. 7 years regulatory experience or other relevant function
- May be specialist in one product type e.g. OTC Medicines, VMS, Medical Devices, Cosmetics
- Detailed understanding of the workings of and key stakeholders in Global Competent Authorities
- Current awareness of legal framework and forthcoming legislation that will affect the business
- People management / team leadership experience desired but not essential – can be first people leadership role with appropriate training put in place
- Strong overall leadership skills with excellence in coaching, negotiation, strategic thinking, prioritisation and effective delegation