What are the responsibilities and job description for the Regulatory Specialist position at EastHORN Clinical Services?
Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase. Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006. The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000 professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.
Our international clients value our enthusiastic, flexible and quality-focused professional approach to meeting their needs, and we are continuing to grow further. To support our future development, we are currently looking for a Regulatory Specialist.
Job summary:
As a Regulatory Specialist you will be expected to assist in regulatory submissions of clinical trial applications and support Clinical Research Associate activities at the study start and perform other administrative duties as assigned by management. We are searching for a positive and energetic person, eager to learn, push forward administative processing of the documents and function well in the project team. Reporting to Regulatory Manager, you will be a key member of the Regulatory Affairs department in Spain. The suitable candidate shall have desire to develop in Regulatory activities and specialise with the time in Regulatory submissions and requirements for Spain.
Main Tasks of the Position:
- Participates in all activities leading to investigational sites activation
- Provides interpretative assistance of guidance documents and regulatory rules applicable for Spain and ensures their communication through company policies and procedures
- Prepares submission packages in cooperation with global team
- Takes part in the communication with Regulatory Authorities and Ethics Committees
- Provides training and support to CRAs in order to collect all necessarily documents for start up package and IP release
- Close collaboration with Regulatory Lead and Project Team during entire project
- Performs tasks according to relevant SOPs and completes the SOPs training in given timelines
Required Qualifications, Experience, Competencies
- Excellent written and oral communication skills in English, Spanish (Portuguese will be an advantage)
- Excellent organizational and time management skills
- Attention to detail
- Ability to work well within a team
- Flexibility, adjustability, initiativeness
- Open to learn new things and communicate across countries and cultures
- Independence in work
- Computer competency
- Previous experience in clinical research field is an advantage
- Background of natural science is an advantage
- Position is highly suitable for Study Coordinators
Benefits:
- Working with experienced and very professional and supportive team
- Possibility to grow within the Company
- Competitive remuneration
- Flexible working time
- Eligibility to the Company Bonus scheme
- Country Specific benefit package