Regulatory Affairs Specialist

The Country Approval Specialist is responsible for managing the preparation, review and coordination of Country Submissions in line with global submission strategy.

• This role will involve preparing, reviewing and coordinating local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with global submission strategy.
• Responsibilities also include providing local regulatory strategy advice (MoH &/or EC) to internal clients.
• You will develop and implement local submission strategy. Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serves as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
• Evaluate guidelines and processes to ensure effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
• A key-contact at country level for all submission-related activities.
• Participates as required in Submission Team Meetings, Review Meetings and Project Team meetings.
• Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are Aligned to the critical path for site activation.
• Achieves PPD's target cycle times for site activations.
• Prepares the regulatory compliance review packages, as applicable.
• Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
• Develops country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Assists in identifying and recognising local out of scope activities in a contract in a timely manner and advise relevant functions.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Evaluate that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
• Oversees country study files and ensures that they meet PPD WPD's or client SOP's
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Key Responsibilities:

• Manage and coordinate regulatory submissions.
• Provide regulatory strategy advice to internal clients.
• Develop and implement local submission strategy.
• Ensure compliance with regulatory guidelines.
• Liaise with internal departments and external partners.

We're looking for an experienced professional to join our team as a Country Approval Specialist. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to work independently.

What We Offer:

• A dynamic and supportive work environment.
• Ongoing training and development opportunities.
• A competitive salary and benefits package.

We're a leading provider of [service/product] solutions, dedicated to helping our clients achieve their goals.

Our Culture:

• We value innovation, teamwork, and customer satisfaction.
• We foster a culture of continuous learning and improvement.
• We prioritize the health and wellbeing of our employees.

Contact Us:
This job description has been designed to provide a summary of the main responsibilities and requirements of the role. It is not intended to be an exhaustive list of every duty associated with the position.
Please note that we welcome applications from all qualified candidates, and we are committed to diversity and inclusion in the workplace.