Be a part of a great team at one of the world's most recognized companies! Our client is a global pharmaceutical and chemical concern with over 100,000 employees worldwide and optimal working conditions.They would like to have a Regulatory Affairs Strategist come and join their Oncology Regulatory Affairs team in Berlin.
Your employer will be Allied Clinical Management, a leader in pharmaceutical research and development in Germany. ACM has collaborated for over 15 years with this client and has developed close connections during this time. The Regulatory Affairs Strategist will work directly at our client's facilities in Berlin, Germany for 13 months. The desired start date is 01 December 2022 with the contract continuing until 31 December 2023 with an option of permanent hire by our client at the beginning of 2024.
Some remote work may be possible.
Responsibilities
You will contribute to the development of local regulatory project goals from development through life cycle.
• You will participate in the preparations for meetings and teleconferences with local HA officials.
• You will collaborate with Lead GRS and supervisor to compile and submit IND and
clinical trial applications to enable timely start of the clinical trials for the assigned development products.
• You will work with Lead GRS and supervisor to develop submission materials for local HA, guides the review process, checks for accuracy, scientific consistency, compliance to local HA regulations and completeness of submission.
• You will collect, review and analyze competitor information, local Agency guidelines and precedence Keeps abreast of changes in the local regulatory environment for the project.
• You will contribute to the development of the Briefing document for the local authority meeting for assigned projects.
• You will be responsible for entering submission material and other documents and
relevant data into appropriate RA databases.
• Where applicable, you will review external and internal communications on local level for regulatory accuracy and local HA compliance.
• You may act as the primary interface between the sponsor and the local Health Authority (HA).
• You may be involved in decision making on key development questions.
• You may participate in ad hoc Global Project Team subteams or working groups as invited by the Global Project Team.
• You may participate in a global regulatory team (GRT) and provided local regulatory input into the global development plan for assigned projects.
Qualifications
• experience in Regulatory Affairs, e.g. preparation and filing of CTAs, INDs, NDAs, MAAs, variations
• Advanced technical degree (Ph.D., D.V.M. or Pharm.D. in life sciences with 2 years direct experience in biomedical research activities.; or MS with 4 years of experience in biomedical activities; or BS with 6 years of experience in biomedical activities.
• Basic knowledge of local Health Authority (HA) regulations (FDA or EMA) to support filings
• Basic understanding of drug development (PK, PD, statistical concepts, data collection, endpoints, etc.)
• A thorough knowledge of policies and procedures in drug development and product maintenance requirements
Nice to Have
• Good communication skills, verbal and written, are required
• Ability to work within a global team framework
• Strong analytical skills are required.
• May have the ability to organize and direct diverse activities in a changing environment often under time pressure.
• Demonstrated problem solving skills as applied to local regulatory issues.
Benefits
- 30 paid vacation days per year
- Contact to a renown and respected global pharmaceutical concern
- Very fair payment is guaranteed
If this sounds like you, we would love to receive your CV and any references. Please apply at the link below.