Specialist, Regulatory Affairs
Multiple Locations: Argentina • Los Ríos Region, Chile
Requisition Number: 649
Position Title: Specialist, Regulatory Affairs
SUMMARY: Responsible for supporting end-to-end site start-up from pre-award feasibility to site activation and maintenance serving as the primary point of contact for the site. This includes supporting pre-award site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification site start-up activities pertaining to Regulatory Authorities submissions under the direction of the Regulatory Affairs team; and liaison with sites to support contracts/budget negotiation under the direction of the Site Contracts team.
- Supports the collection of country and site level intelligence, as per Worldwide internal procedure.
- Performs pre-award feasibility studies for potential sites as requested.
- Supports the development of a preliminary potential site list.
- Supports Site Identification activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Site Identification Questionnaires.
- Supports the development and adaptation of country/site specific informed consent forms.
- Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities.
- Interfaces with relevant functional leads to ensure appropriate prioritization of essential document collection and review to facilitate synchronized start-up.
- Collects, receives, perform first review of required study-specific site regulatory/essential in accordance with applicable SOPs, guidelines and relevant study specific plans. Implements corrective action as needed, prior to essential document review sign off and follow up on Non-Hold items post sign off (where applicable).
- Tracks study-specific site regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the Project Manager or Site Activation Lead.
- Where applicable, provide local follow up and updates of status of local EC submissions to the Regulatory Affairs and relevant teams assigned to the project.
- Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate.
- Supports of translations as per Worldwide internal SOP.
OTHER SKILLS AND ABILITIES:
- Good oral and written communication skills.
- Good planning and organizational skills with effective time management.
- Good interpersonal skills.
- Good understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
- Ability to work in an organized, methodical and self-motivated manner.
- Good understanding of clinical research principles and process.
- Good understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and country/local regulatory requirements.
- Ability to proactively identify and solve problems.
- Good understanding of standard operating procedures.
- Proficient knowledge of Microsoft Office and other contemporary software applications.
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
- Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and one year experience with clinical research (e.g. study coordinator, CTA, etc.)
- Preferable CRO/pharmaceutical industry experience.
- Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English.
State: Baja California
Employment Type: Regular
Community / Marketing Title: Specialist, Regulatory Affairs
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.