Regulatory Affairs Assistant (Remote-Mexico)

Requisition Number: 3334

Position Title: Site Activation & Regulatory Assistant

External Description:

The Regulatory Affairs Assistant provides general and project specific administrative support to Regulatory Affairs and Site Activation team during study start-up and maintenance stages.
 
RESPONSIBILITIES:
Tasks may include but are not limited to:
 

• Assist with the coordination of regional/departmental improvement initiatives
• If applicable, under the direction of a senior member of the department, coordinate & manage compilation of regulatory & ethics committee submissions throughout assigned countries
• Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF, labels, among others
• Pack and dispatch regulatory submissions and site documents, and follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools
• Perform administrative QC of regulatory submissions and site documents to ensure correct completeness and formatting
• Liaise with Finance requesting fee payment to Regulatory Authorities and ECs
• If applicable, contribute as owner or support of Country Intelligence Pages
• Ensure department specific study files are submitted to TMF and are consistently audit/inspection ready
• Prepare and submits hardcopies or electronic copies of site essential documents for storage at Central Records as required
• Support administrative activities by archiving regional/departmental communication and assisting with generation of slides
• Ensure Regulatory & Site Activation pieces on Investigator Site Files are properly provided to study team and CTA for accurate ISF preparation and shipment
• Provide support to Feasibility activities when required
• Manage third party vendors such as printing and courier service providers at regional level
• Provide general administrative assistance for the smooth running of the department in the region – organize meetings and record minutes, manage diaries, etc

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
 

OTHER SKILLS AND ABILITIES:
 

• Clearly, proven organizational and time management skills are essential attributes
• Excellent written and verbal communication skills to clearly and concisely present information
• Good interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Proactive and excellent ability to handle multiple tasks
• Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
• Excellent self-motivation skills
• Willingness to adapt to new procedural requirements

Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

 
REQUIREMENTS:
 

• 2 years office/business experience in a supporting role
• Preferable CRO/pharmaceutical industry experience.
• Bachelor’s degree or equivalent preferred
  

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City:

State:

Employment Type: Regular

Community / Marketing Title: Regulatory Affairs Assistant (Remote-Mexico)

Company Profile:

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.

Location_formattedLocationLong: Austin, Texas US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.