Regulatory Affairs Manager (m/f/x) - Innovation & new Initiatives | Stuttgart | 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 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 food chemistry, food technology, pharmacy, nutritional science, health-related science
- At least 3-4 years of experience in regulatory Affairs in the pharmaceutical industry
- 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 action
- 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 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
- This is a Headquarter position and needs regular presence on site!
About the Client:
Our client is an international pharmaceutical company with about 1000 employees in more than 30 countries. The company has been completely family-owned from the very beginning (founded in 1971) and develops and sells biofactor and generic products. The product range includes prescription drugs as well as OTC products and dietary supplements. As part of a large-scale growth initiative, the company plans to multiply its turnover in the coming years.
My contact details:
- Email: m.inderhees@sciproglobal.de
- Tel: 0049 (0) 89/26 20 09 25 (direct dial)
- Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
- LinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/
I look forward to your application!
