Senior Specialist Study Start Up & Regulatory Affairs

The Senior Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related
to achieving site initiation readiness. The role provides subject matter expertise, ensures regulatory
compliance, and serves as a key liaison between internal teams, clients, and external stakeholders.
ROLE AND RESPONSIBILITIES
Accountable for delivery of assigned study start-up and regulatory milestones within defined scope.
Make independent decisions within assigned scope regarding regulatory processes and documentation approaches.
Handles medium-complexity regulatory environments, including multi-country requirements where applicable.
Leads study start-up and regulatory activities for assigned countries or projects of medium complexity, ensuring delivery in line with timelines, quality standards, and regulatory requirements.
Leads preparation, review, and quality control of regulatory and study start-up documentation (including submissions, essential documents, and translations) to ensure completeness, accuracy, and compliance with ICH-GCP and country-specific requirements.
Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations and within the projected delivery timelines.
May collaborate with internal and external legal, finance and clinical operations department including communicating and explaining legal and budgetary issues in relation to countries of assignment.
Responsible for site outreach in assigned country/countries; point of contact for site, sharingof non-confidential and confidential study information and management of confidential disclosure agreements.
Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation readiness.Review all relevant documentation e.g. labels, patient information sheets, diary cards, insurance etc, to ensure compliance with ICH GCP & country specific requirements.
Contribute towards the preparation and/or review of complex technical/scientific/legal documentation.
Arrange for and/or review translation of essential documents as required
Provide regulatory/SSU strategic input to internal and external customers. Develop the regulatory strategy and the SSU Plan, joint operating procedures and core documents
Promptly identify and escalate risk/potential risk to the project team which may jeopardise deliverables; support corrective/preventive actions
Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
Provide expert advice to Clients addressing complex regulatory queries and liaison with authorities
Acts as country or regional subject matter expert for all regulatory and CSA elements on assigned studies for internal and sponsor stakeholders alike and ensures country intelligence is up to date in country intelligence repositories and any changes promptly disseminated
Ensure timely and accurate completion of project trackers, correspondence log filing in study portal and TMF, and QC of submission dossiers
Provide support to BD proposal development and input to budgets, provide department representation to BD meetings as required.
Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required.
Provide input to department / company initiatives and contribute to the design/review of
SOPs/working practice/guidance.
Provide training, coaching and mentoring to junior members of staff.
Performs other work-related duties as assigned.
Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent combination of education and experience
Previous experience within the pharmaceutical/CRO industry
Good knowledge of ICH GCP and national regulations for territories of competency
Good written and verbal communication skills to clearly and concisely present information
Proficiency in English, both written and verbal
Excellent planning and organizational skills
Strong planning, strategizing, managing, monitoring,
scheduling, problem-solving and critiquing skills Excellent
ability to manage multiple tasks, set priorities, and adapt to
changing work assignments
Ability to exercise sound judgment and make decisions
independently
Effective written and verbal communication skills to clearly
and concisely present information
Remarkable attention to details
Excellent self-motivation and motivation skills

Employment type
Full-time

Work arrangement
Yes