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
- 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: firstname.lastname@example.org
- 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!