Team Lead Regulatory Affairs

Randstad Danmark; Köln; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

An international pharmaceutical company in Cologne is hiring a Regulatory Affairs Lead to guide a dedicated team through daily operations and digital transformation. You will balance leadership with executing regulatory tasks and ensure compliance, documentation, and licensing for parallel imports. Candidates should possess strong operational skills in Regulatory Affairs, fluency in German and English, and a background in natural sciences. Join this growing team and contribute to shaping their future success.

Qualifikationen

• Solid operational experience within Regulatory Affairs.
• Experience with parallel import or wholesale of medicines is advantageous.
• Previous leadership experience is a plus, but a strong specialist with the right mindset is also welcome.

Aufgaben

• Conduct leadership meetings and performance reviews.
• Create and maintain repackaging instructions.
• Apply for and maintain licenses for parallel import of pharmaceuticals.
• Handle communication with authorities for compliance.
• Manage Master Data for digital transformation.

Kenntnisse

Strong operational skills in RA

Fluent in German and English

Proficient IT user (MS Office)

Ausbildung

Background in natural sciences or vocational training

Tools

MS Office

ERP systems like Navision or D365

Jobbeschreibung

Can you lead a dedicated team through a digital transformation while keeping a steady hand on daily operations? Join 2care4 in Cologne and play a key role in our German growth journey.

Your new role offers a unique combination of leadership and specialist tasks. You will be the stabilizing force that ensures quality in the daily work while helping 2care4 transition into a scalable process in Microsoft D365.

Job

You step into a playing coach role where you balance leadership with operational execution. You spend most of your time solving complex regulatory tasks alongside leading your team.

You act as a stabilizing link between management and your team. By translating decisions into clear goals and prioritizing incoming information, you create a focused environment where your colleagues can thrive. Your steady hand ensures stability in a changing landscape, keeping the German office a central part of 2care4’s growth.

Your direct manager is Head of Regulatory Affairs who is situated in the 2care4 HQ in Esbjerg. You will interact mostly on Teams and via email communication, but you will also meet in person several times per year, either at HQ or at the office in Cologne.

Team

You will lead 4 experienced specialists who cover the full spectrum of Regulatory Affairs in Germany. They manage everything from repackaging instructions and packing materials to trademark notifications and contact with authorities.

The team is self-driven and shares responsibilities to ensure flexibility. A major focus for the team right now is Master Data Management and the upcoming transition to D365. You also work closely with the 3 other Team Leads in the department, based in Denmark and Poland, to ensure that you all pull in the same direction.

Main responsibilities

• Leadership: You conduct 1 : 1 meetings, yearly performance reviews / PDDs, handle salary reviews, and plan resources to keep the team motivated and efficient.
• Documentation: You create and maintain repackaging instructions and approve packing materials.
• Licensing: You apply for and maintain licenses for the parallel import of pharmaceuticals.
• Compliance: You handle communication with authorities and ensure that the company's QMS guidelines and SOPs are always up to date.
• Digital Transformation: You manage Master Data in the current systems and ensure safe transition for the team towards D365.

Qualifications and competencies

You likely have a background in natural sciences (pharmacy / healthcare) or have completed vocational training. The most important factor is your solid operational experience within Regulatory Affairs.

Need to have

• You have strong operational skills in RA and can solve specialist tasks independently.
• You speak and write fluent German and English.
• You are an experienced IT user (MS Office), and you are ready to champion our digital tools.

Nice to have

• Experience with parallel import, wholesale of medicines, or handling narcotics.
• Previous leadership experience is a plus, but if you are a strong specialist with the right "drift" mindset ready to step up, we want to hear from you.
• Knowledge of ERP systems like Navision or D365.

Personal profile

You are calm, stable, and caring. In a busy environment, you are the one who keeps a cool head and does not create unnecessary drama. You possess integrity and dare to speak your mind—you act as a sparring partner to the management rather than just a "yes-sayer." You thrive in a matrix organization where you collaborate across borders to achieve common goals.

Application and contact

Randstad Denmark manages the recruitment process on behalf of the company. If the position has caught your interest, please apply for the role through this site.

For more detailed information regarding this position, please contact senior consultant Jakob Kløverpris Rindum on [phone] or [e-mail]. All inquiries will be handled confidentially.

About 2care4

Founded in 2005 in Esbjerg, 2care4 is an international pharmaceutical company that has experienced rapid growth, with approximately 360 employees across Europe. The core business is the parallel import of medicine, involving purchasing original medicine in EU / EEA countries and repackaging it for local markets. The company's purpose is to create "savings for society through dedication" by increasing competition. As part of its German growth strategy, 2care4 Group acquired the German company ALLOMEDIC.

About Randstad

Randstad is the world’s largest talent company and a partner of choice to clients. As a Partner for Talent, we are committed to providing equitable opportunities to people from all backgrounds and helping them remain relevant in the rapidly changing world of work.

We have a deep understanding of the labour market and help our clients to create the high-quality, diverse and agile workforces they need to succeed. We support people to realise their true potential throughout their entire working life. This is what we do and what motivates us every day.

Randstad DK is part of the international Randstad Group. Every day, we help more than 600,000 people around the world find jobs. We specialise in finding, attracting, and retaining skilled talent to power businesses at speed and at scale. Randstad DK is a leader in this field, with offices in Copenhagen, Aarhus, Aalborg, and Kolding.