Senior Country Approval Specialist

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Prepare, review, and coordinate local regulatory submissions in accordance with the global submission strategy.

• Offer local regulatory strategy guidance to internal stakeholders.

• Develop and execute local submission strategies.

• Provide technical expertise and oversight through collaboration with internal departments.

• Act as the primary liaison for investigators and local regulatory authorities.

• Ensure adherence to guidelines and processes for communications with internal teams, investigators, and regulatory authorities.

• Serve as the key country-level contact for activities related to submissions.

• Participate in Submission Team, Review, and Project Team meetings.

• Coordinate site start-up activities with internal functional teams and harmonize submissions with site activation critical paths.

• Meet company target cycle times for site activations.

• Prepare packages for regulatory compliance reviews.

• Oversee local submission activities in line with the global project submission strategy.

• Create country-specific Patient Information Sheet and Informed Consent Form documents.

• Assist with grant budgets and negotiate payment schedules with sites.

• Identify local out-of-scope contract activities and advise relevant functions accordingly.

• Support feasibility activities in alignment with agreed timelines.

• Maintain accurate and up-to-date trial status information in the database.

• Supervise country study files to ensure compliance with PPD WPD or client SOPs.

• Keep informed of PPD SOPs, client SOPs/directives, and current regulatory guidelines.

• Direct or mentor assigned Start-Up personnel.

• Proactively identify, address, or escalate issues related to regulatory processes.

⛳️ Requirements

• Bachelor's degree or an equivalent qualification with relevant formal academic or vocational training.

• Over 5 years of prior experience providing the necessary knowledge, skills, and abilities to perform the role.

• An equivalent combination of suitable education, training, and/or directly related experience may fulfill the role requirements.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• High attention to detail and quality in documentation.

• Proficient negotiation skills.

• Competent computer skills and willingness to learn necessary software.

• Proficient in English language and grammar.

• Good judgment and decision-making capabilities.

• Basic understanding of medical/therapeutic areas and medical terminology.

• Ability to work effectively in a team environment or independently with minimal supervision.

• Capability to mentor fellow Start-Up team members.

• Excellent team player with strong teambuilding skills.

• Strong organizational and planning abilities.

• Familiarity with applicable regional/national regulatory guidelines and EC regulations.

🏝️ Benefits

• Fully remote work arrangement.

• Global team environment.

• Opportunities for collaboration and professional development.

• A culture centered on passion, innovation, and scientific excellence.