Senior Country Approval Specialist

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

📋 Description

• Prepare, review, and coordinate local regulatory submissions (MoH, EC, and any additional special national local applications if applicable, in alignment with the global submission strategy).

• Provide local regulatory strategy guidance (MoH &/or EC) to internal stakeholders.

• Develop and execute the local submission strategy.

• Offer technical expertise and oversight for projects in collaboration with relevant internal teams.

• Act as the primary liaison for investigators and local regulatory authorities to ensure timely management of submissions.

• Ensure adherence to guidelines and processes for effective communication within the internal team, as well as with investigators and the country regulatory authorities, to guarantee timely submission management.

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

• Participate in Submission Team Meetings, Review Meetings, and Project Team meetings as necessary.

• Coordinate with internal functional departments to ensure various site start-up activities align with submission activities and agreed timelines.

• Meet the company's target cycle times for site activations.

• Prepare regulatory compliance review packages as applicable.

• Collaborate with the SSU team locally to ensure that local submission activities are planned and executed according to the global project submission strategy.

• Develop country-specific Patient Information Sheet/Informed Consent form documents.

• May assist with negotiating grant budgets and payment schedules with sites.

• Help identify and recognize local out-of-scope activities in contracts promptly and advise relevant functions.

• Ensure that trial status information related to SSU activities is accurately maintained in the database and is current at all times.

• Oversee country study files, ensuring compliance with PPD WPD’s or client SOPs.

• Maintain up-to-date knowledge of PPD SOPs, Client SOPs/directives, and current regulatory guidelines relevant to the services provided.

• Direct and mentor other SSU individuals assigned to projects of responsibility, as appropriate.

• Proactively identify issues or discrepancies in the regulatory process of a study and resolve or escalate as necessary.

⛳️ Requirements

• Bachelor's degree or an equivalent and relevant formal academic/vocational qualification.

• Prior experience that equips the candidate with the knowledge, skills, and abilities to perform the job (approximately 5+ years).

• Proficient oral and written communication skills.

• Strong interpersonal skills.

• Exceptional attention to detail and quality of documentation.

• Competent negotiation skills.

• Good computer skills with the ability to learn relevant software.

• Proficient English language and grammar skills.

• Strong judgment and decision-making abilities.

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

• Ability to work both in a team environment and independently, with minimal supervision when required.

• Capability to mentor fellow SSU team members in a constructive and effective manner.

• Excellent team player with team-building skills.

• Fundamental organizational and planning skills.

• Comprehensive understanding of all applicable regional/national regulatory guidelines and EC regulations.

🏝️ Benefits

• Health insurance.

• Paid time off.

• Flexible work arrangements.

• Professional development opportunities.