Senior Country Approval Specialist / Principal Country Approval Specialist

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

📋 Description

• Prepare, review, and coordinate local regulatory submissions (MoH, EC, and any additional special national local applications, such as gene therapy approvals, viral safety dossiers, and import licenses) in accordance with the global submission strategy.

• Offer advice on local regulatory strategy (MoH &/or EC) to internal clients.

• Develop and implement a local submission strategy.

• Provide technical expertise and oversight for project coordination in collaboration with relevant internal departments.

• Act as the primary contact for investigators and local regulatory authorities (working with the local regulatory manager on complex issues) to ensure timely management of submissions.

• Ensure adherence to guidelines and processes for effective internal team communications, as well as communications with investigators and country regulatory authorities to manage submissions promptly.

• Serve as the main 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 that various site start-up activities align with submission activities and mutually agreed timelines; ensure the alignment of the submission process for sites and studies with the critical path for site activation.

• Achieve the company’s target cycle times for site activations.

• Prepare regulatory compliance review packages, as necessary.

• Collaborate locally within SIA to ensure that local submission activities are planned and executed in alignment with the global project submission strategy.

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

• May assist with grant budgets and payment schedule negotiations with sites.

• Help identify and flag local out-of-scope activities in contracts promptly, advising relevant functions.

• Support the coordination of feasibility activities as needed, in accordance with agreed timelines.

• Ensure that trial status information pertaining to SIA activities is accurately maintained and up-to-date in the database at all times.

• Oversee country study files, ensuring compliance with PPD WPDs or client SOPs.

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

• Direct and mentor other SIA team members assigned to support projects as appropriate.

• Proactively identify issues or anomalies in the regulatory processes of a study and resolve or escalate them as necessary.

⛳️ Requirements

• Bachelor’s degree or equivalent along with relevant formal academic/vocational qualifications.

• Prior experience that equips the candidate with the knowledge, skills, and abilities to perform the role (comparable to 5-8 years).

• Strong oral and written communication skills.

• Excellent interpersonal skills.

• High attention to detail and quality of documentation.

• Proficient negotiation skills.

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

• Strong English language and grammar skills.

• Sound judgment and decision-making abilities.

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

• Capacity to work both in a team environment and independently, with minimal supervision as needed.

• Ability to mentor fellow SIA team members positively and effectively.

• Excellent team player with teambuilding capabilities.

• Basic organizational and planning skills.

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

🏝️ Benefits

• Health insurance.

• 401(k).

• Flexible work arrangements.

• Paid time off.

• Professional development.