Associate Director Global RA Operations
MSD is working to help the world be well. Through their medicines, vaccines, biologic therapies and animal health products, they work in more than 140 countries to deliver innovative health solutions to patients and animals. MSD also demonstrate their commitment to increasing access to health care through far-reaching programs that donate and deliver their products to the people who need them. MSD has a workforce of almost 4500 in the Netherlands at three main sites. MSD is also known as Merck & Co., Inc. in the US and Canada & Puerto Rico.
MSD Animal Health is a global biopharmaceutical leader with a diverse portfolio of vaccines and animal health products.
The Global Regulatory Affairs (RA) is part of the Global Research & Development organization and is globally accountable for licensing and maintenance of pharmaceutical and biological animal health products. Within Global Regulatory Affairs, the Operations department, located in Boxmeer (the Netherlands) is responsible for the regulatory data and document infrastructure, the electronic publishing of registration files and the global management of labeling documents.
Purpose of the role:
In this position you provide direction, vision, coaching and guidance to a team of approximately 20 people (3 direct reports) involved in the various disciplines of the Operations team Artwork Management, Publishing, Regulatory Information Management).
- Management of the end-to-end process related to product artwork including contract and performance management of 3rd party vendors, management of controlled records for artwork changes, continuous process improvement as well as special artwork projects;
- Definition and implementation of state-of-the-art Global Regulatory Affairs data and document infrastructure covering document lifecycle (creation, handling, publishing and archiving);
- Ensure full compliance with applicable internal and external policies and regulations;
- Anticipate changes in regulatory requirements;
- Pro-actively support and facilitate time-to-market of new product developments and effective product maintenance of existing products in close cooperation with other stakeholders;
- Function as key operational interface towards (country) Regulatory Affairs, Global Marketing, Manufacturing, Quality, Supply Chain and IT for regulatory and artwork management platforms;
- Take over system administration and platform system ownership responsibilities.
Challenge in the position
In a world of rapid innovation, MSD AH seeks brave Inventors who want to make an Impact in all aspects of the business, enabling breakthroughs that will affect generations to come. They encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to their organization. Together you will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
MSD AH is proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. They encourage colleagues to respectfully challenge one another’s thinking and approach problems collectively. They are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
- or in Life Sciences; pharmacy, biology, chemistry, biochemistry or supply chain;
- Minimum of of labeling, quality management, manufacturing, supply chain or compliance;
- Good stakeholder management and proven management skills with a minimum of of as people manager;
- Strategic thinking combined with commercial awareness focus on results;
- Working with information systems and platforms used for labelling;
- in data management and standardization is preferred;
- It’s a preference if you have working with registration processes and change management;
- Negotiation skills; ability to interpret and explain (complex) information.
Information & application:
Marije Hoogendoorn | Sr. Recruitment Specialist
+31 - 6 - 23 13 51 18 | email@example.com
Marjo Lucker | Recruitment Consultant
+31 - 6 - 13 56 19 88 | firstname.lastname@example.org