Global Regulatory Affairs Manager - ATMP (m|f|d)
at Miltenyi Biomedicine
5BG, Nordrhein-Westfalen, Germany -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 30 Jul, 2024 | Not Specified | 05 May, 2024 | N/A | Biology,Communication Skills,Product Safety,Regulatory Requirements,Maintenance,Drug Development,Biologics,Chemistry,Cross Functional Relationships,Regulatory Science,Risk Management Plans,German,English,Regulatory Interactions,Regulatory Affairs | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
MILTENYI BIOMEDICINE IS A BIOPHARMACEUTICAL COMPANY DEVELOPING PERSONALIZED CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPIES. WE ARE DEVELOPING INNOVATIVE TREATMENTS FOR SERIOUS LIFE-THREATENING DISEASES AND ARE RESHAPING THEIR ACCESSIBILITY TO PATIENTS WORLDWIDE WITH THE GOAL OF IMPROVING AND PROLONGING PATIENTS’ LIVES. WE ARE CURRENTLY FOCUSING ON DIFFICULT-TO-TREAT HEMATOLOGICAL CANCERS USING CAR-T AND OTHER TECHNOLOGIES, WHILE ALSO EXPLORING TREATMENTS FOR OTHER DISEASES. OUR LEAD CANDIDATE, CURRENTLY IN PIVOTAL CLINICAL TRIALS GLOBALLY, IS A TANDEM CAR T-CELL PRODUCT.
Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages.
Job Description
- You will be responsible for managing and leading regional teams of regulatory affairs professionals in the EU and EMEA for new and approved products on a national or international basis.
- This includes coordinating strategic regulatory activities with full staff and product management authority, as well as regional regulatory strategy and planning in line with the global regulatory strategy.
- Working closely with health authorities to coordinate, communicate and manage all regulatory interactions is another essential part of this position.
- You will also oversee relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements.
- Leading the development and maintenance of prescribing information and risk management plans completes the diverse range of responsibilities.
QUALIFICATIONS
- M.D., Ph.D., or Master’s degree in pharmacy, biology, chemistry, or a related field. An advanced degree or certificate in regulatory science is preferred, but not required.
- Several years of relevant experience in EU regulatory affairs, drug development and/or submission management with a focus on ATMPs and biologics.
- Sound business judgment and collaborative skills, as well as proven ability to interact and influence at all levels of a dynamic organization.
- Ability to build and maintain strong cross-functional relationships, to challenge traditional views while respecting best practices, and to present and argue cases in a professional and respectful manner.
- You have a proven track record of successfully leading and developing a team.
- You are a self-starter with excellent organizational and communication skills in English, basic skills in German are preferred, but not required. Willingness to travel internationally (10%)
Additional Information
Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Trade Certificate
Regulatory science is preferred but not required
Proficient
1
51429 Bergisch Gladbach, Germany