Senior Consultant – Regulatory - remote (m/w/d)

Work set-up: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Bachelor's degree or higher in Biology, Chemistry, Biochemistry, Pharmacy, Biomedical Science, Health Science, Computer Science, or related field., Up to 5 years of experience in Regulatory Operations and Regulatory Information Management within the Pharmaceutical Industry., Strong understanding of regulatory processes, data management, and compliance requirements., Interest in digital transformation, data-driven regulatory submissions, and process automation..

Key responsibilities:

  • Collaborate with MAIN5 consultants on projects like RIMS implementations and health authority requirements.
  • Manage deliverables and ensure project outcomes meet customer expectations.
  • Contribute to internal knowledge sharing and learning initiatives.
  • Support the promotion of MAIN5's values and work methods.

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MAIN5 Scaleup http://www.main5.de/
51 - 200 Employees
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Job description

Your mission
  • Work with other MAIN5 consultants in projects like RIMS system implementations, Health Authority requirements like IDMP, regulatory data management, data quality. 
  • Take responsibility of deliverables in projects, collaborate with other MAIN5 consultants and customers in projects to deliver in line with customer expectations and needs. 
  • Enhance your expertise and personal development by collaborating with MAIN5 experts on project-related work and engaging in internal learning and knowledge-sharing initiatives. 
  • Advocate MAIN5's values and methods of work. 
  • Foster a culture of knowledge sharing and learning from each other. 
  • Join the MAIN5 family to become part of a dynamic community.
Your profile
  • Bachelor’s degree or higher in Biology, Chemistry, Biochemistry, Pharmacy, Biomedical Science, Health Science, Computer Science or related field. Alternatively, applicants with similar educational backgrounds or certifications and a minimum of relevant practical work experience are also welcome to apply.  
  • You have up to 5 years of experience in the Pharmaceutical Industry in the area of Regulatory Operations and Regulatory Information Management. 
  • You are passionate when it comes to driving digital transformation in Life Sciences, enabling data driven regulatory submissions, and automating processes. 
  • You have a solid understanding of regulatory processes and regulatory data, with the ability to apply this knowledge strategically to support business functions, lead regulatory projects, and drive initiatives that enhance operational efficiency and ensure compliance with Health Authority requirements.
  • You have a keen understanding in data management, including Data Governance and Master Data Management and would like to deepen your expertise in these areas, ideally with first practical experience. 
  • You have an affinity to understand business requirements and technology which enables you to translate between both effectively. 
  • You have strong analytical and problem-solving skills, with attention to detail and the bigger picture. 
  • As a communicative team player, you can work effectively in a collaborative environment
Why us?
  • We offer exciting tasks and projects in an interesting market segment with high-caliber clients & topics
  • You will work in an international environment and be part of a highly motivated and excellent team
  • You will receive an intensive induction and be integrated into your team, which is characterized by its helpfulness and communication at eye level
  • You will benefit from flexible working hours in a home office in a dynamically growing company with above-average earning potential
  • We offer a secure job with long-term prospects for personal development
  • We also offer a wide range of internal and external training opportunities
  • Other benefits include working from home, a pleasant and creative working atmosphere and company events
About us

MAIN5 GmbH & Co. KGaA is an independent, international and successful management consulting company headquartered in Frankfurt am Main. We provide sustainable and reliable solutions for our clients' key issues in the field of digital transformation, each of which is highly relevant in the face of growing international competition. Our focus is on leading international companies in the life sciences sector. This is the sector in which we are at home and in which we have a track record of sustainable success through the design and implementation of forward-looking methods, strategies and solutions.


Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Analytical Skills
  • Problem Solving
  • Detail Oriented
  • Teamwork
  • Communication

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