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Regulatory Affairs Manager (m/f/x) Initiatives

  • Location: Baden-Württemberg
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 5 months ago

  • Sector: Pharmaceutical
  • Contact: Marlene Inderhees
  • Contact Email:
  • Expiry Date: 09 June 2023
  • Job Ref: 51_2023_1683731143

Regulatory Affairs Manager (m/f/x) new Initiatives | BAWÜ | Pharma

Our client has to offer a very interesting story as they are in the middle of a huge "Go4Growth" Initiative which sees them hiring across several areas, trying to add new know-how, ways of working and great humans in general.

The area of food supplements will - with this hire - get a whole new level of attention in the company's strategy moving forward. We are looking for a very dynamic and driven personality to join their Regulatory Affairs New Initiatives team, focusing on several Innovation Projects working in a Matrix environment. You would be the "Regulatory Representative" and support the drive for new innovations with you background in RA and food supplements / ingredients.

What will your tasks as Regulatory Affairs Manager (m/f/x) be?

  • Review and plan assigned new submissions, in-licensing projects and other initiatives, identify peaks & Adjust timings/priorities where possible with no/minimal commercial impact
  • Definition of regulatory and pharmaceutical requirements for submissions in close cooperation with local Regulatory Colleagues & Advisors,
  • Leading and coordinating application processes including post-approval changes required for the Launch of new products
  • Close cooperation and communication with other departments, consultants, CMOs as well as with affiliates, including proactive advice on potential regulatory risks and recommending the best regulatory strategy
  • Actively contribute to important departmental outcomes such as strategy development, budgeting, Compliance activities
  • Communicate & act as point of contact towards stakeholders regarding defined New Initiatives & Innovation (NII) related topics & projects

Your requirements?

  • Bachelor/master's in pharmacy, veterinary medicine health-related science
  • At least 4 years of experience in regulatory Affairs in the pharmaceutical industry or in a regulatory authority
  • depth knowledge of the legal and regulatory requirements of medicinal product at least in EU
  • Precise, analytical, self-motivated, integrative and responsible way of working, value-oriented and corporate mindset and actionsss
  • Demonstrated excellent organisational and project management skills as well as the ability to work in rotating teams in a matrix structure and perform tasks to a high level in a detail-oriented way in spite of strict deadlines

Essential knowledge & skills:

  • Very good written and spoken English; knowledge of German and other languages is an advantage
  • Reliability, team spirit, initiative, cross-departmental thinking and the ability to manage several projects simultaneously

What does the position of Regulatory Affairs Manager (m/f/x) offer you?

  • Salary: base salary + 13th salary
  • Contract type: unlimited
  • Vacation: 30 days / year
  • Working time: 40 hours / week
  • Accessibility: Very good transport connections by public transport; sufficient parking spaces available
  • Start date: At the next possible date
  • Homeoffice: 75% remote

My contact details:

  • Email:
  • Tel: 0049 (0) 89/26 20 09 25 (direct dial)
  • Xing:
  • LinkedIn:

I look forward to your application!