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Team Lead - Global Regulatory Affairs Operations

Geplaatst 24 mrt. 2024
Werkervaring
5 tot 7 jaar
Full-time / part-time
Full-time
Soort opleiding
Taalvereisten
Engels (Vloeiend)
Nederlands (Vloeiend)

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Job Description

Did you always want to work in a company where your work can have a real impact? Do you enjoy working in an international environment with lots of room for personal development? Do you have experience in guiding multi-disciplinary project teams? We would like to meet you!

We have an exciting opportunity for a

Team Lead to guide our Global Regulatory Affairs Operations

Purpose of the role

In this position you provide direction, vision, coaching and guidance to a team of approximately (direct and indirect) 20 people involved in the various disciplines of the Operations team Artwork Management, Publishing, Regulatory Information Management).

Your key tasks will include:

  • 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

Welcome in our team

Global Regulatory Affairs is part of the Global Research & Development organization of our company and is accountable for licensing and maintenance of pharmaceutical and biological animal health products globally. Within Global Regulatory Affairs, our 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.

Your profile

  • Bachelor or Master degree in Life Sciences; pharmacy, biology, chemistry, biochemistry or supply chain;
  • Minimum of 5 years of experience in labeling, quality management, manufacturing, supply chain or compliance
  • Good stakeholder management and proven management skills with a minimum of 3 years of experience as people manager
  • Strategic thinking combined with commercial awareness focus on results;
  • Working experience with information systems and platforms used for labelling
  • Experience in data management and standardization is preferred;
  • It’s a preference if you have working experience with registration processes and change management;
  • Negotiation skills; ability to interpret and explain (complex) information.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

We are 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. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

MSD als werkgever
Keer op keer nieuwe uitdagingen aangaan, dat is wat bij je moet passen als je bij MSD aan de slag wilt. Want continu verbeteren is een van onze drijfveren. Dat geldt zowel voor werkprocessen als voor medewerkers. Gedrevenheid, teamwork en eigen initiatief zijn van groot belang. Bij MSD kun je je op allerlei manieren ontwikkelen. In de…


MSD als werkgever
Keer op keer nieuwe uitdagingen aangaan, dat is wat bij je moet passen als je bij MSD aan de slag wilt. Want continu verbeteren is een van onze drijfveren. Dat geldt zowel voor werkprocessen als voor medewerkers. Gedrevenheid, teamwork en eigen initiatief zijn van groot belang. Bij MSD kun je je op allerlei manieren ontwikkelen. In de diepte, door je te specialiseren in je vak. Maar ook door jezelf te verbreden en door te groeien naar een leidinggevende functie. Internationaal of juist heel lokaal, er zijn talloze andere mogelijkheden om stappen te zetten in je loopbaan, te rouleren in functies of te groeien in je functie. Werken bij MSD is werken in een dynamische high tech omgeving van internationale allure, die toch sterk lokaal geworteld is in Oss, Haarlem en Boxmeer.

Farmaceutisch
Haarlem
5.600 medewerkers