Regulatory Affairs Associate
vor 2 Wochen
Regulatory Affairs Associate
Company: We are Immutep, an emerging international biotechnology company developing immunotherapeutic products for cancer and autoimmune diseases. With operations based in Australia, Germany and France, Immutep is dedicated to bringing innovative treatment options to the market for patients. The company is publicly traded on the ASX and NASDAQ.
Location: Berlin, Germany; full-time, hybrid role (office/remote).
Summary: As a result of continuous progress in our projects we are hiring a Regulatory Affairs (RA) Associate. You will be responsible for supporting and coordinating internal regulatory processes and organizing submissions to relevant authorities. Furthermore, you are responsible for gathering and maintaining knowledge of relevant regulations (EMA, FDA, ICH). You will be collaborating closely with the internal medical and clinical teams.
Job description:
- Support and coordinate the preparation and submission of applications to competent authorities, ethics committees, and Independent Review Boards for clinical trials, reports, and correspondence (globally).
- Support the company’s interactions with regulatory authorities, e.g. FDA meetings, scientific advice, orphan drug designation, expedited programs etc.
- Responsible for compiling submission/scientific advice packages as assigned.
- Responsible for organizing timelines and finalizing documents needed in RA processes (e.g. IND) both at the clinical trial and general levels.
- Responsible for filing RA documents, both digital and physical, in accordance with Standard Operating Procedures (SOPs).
- Communicate with external partners to support our regulatory affairs projects (e.g. consultants, subcontractors, clinical research organizations).
- Ensure regulatory compliance of the company’s product candidates and anticipate/navigate regulatory obstacles.
- Provide support for product development, due diligence processes and internal/external company communications with regulatory input.
- Responsible for tracking of regulatory activities.
Required skills/experiences/qualifications:
- Background in natural/ life sciences or medicine
- Knowledge and experience in relevant legislation and international guidelines for drug development.
- Minimum of 1 year of experience in RA, including pre-authorization tasks such as clinical trial submissions and responding to competent authority requests.
- Experience in the FDA regulatory domain, including knowledge of IND setup and maintenance.
- Practical experience in scientific advice meetings with FDA or EMA is a plus.
- Knowledge and experience in (immuno-) oncological drug development is a plus.
- Refined conversational skills in German (written and spoken) are a plus.
- Very good English (written and spoken).
- Very good knowledge of standard software (Word, Excel, Outlook, Power Point).
Job expectations:
- Multifunctional tasks in the emerging field of immune therapeutics.
- Be part of the development of a “first in class” drug.
- Highly motivated and energetic international team.
- 1 year contract, starting September 2024, hybrid (office/remote).
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