**Job Description:**
We are seeking a highly skilled Regulatory/Senior Regulatory Scientist to join our team. As a key member of our clinical development organization, you will be responsible for ensuring the timely preparation and submission of regulatory documents to support the approval of clinical trials.
Responsibilities:
* Completes country and/or regional Clinical Trial Regulatory deliverables according to study specifics, company policies, procedures, applicable regulations, and the principles of ICH-GCP with sound scientific/technical principles in line with contractual agreement.
* Becomes involved in staff training/mentoring and contributes to the review of company systems and procedures as appropriate.
* Ensures regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies, and procedures within contractual timelines and budget with sound scientific/technical principles.
* Has advanced knowledge of company SOPs/WIs, ICH, GCP, and appropriate regulations.
* Has advanced knowledge of company systems applicable to role.
* Has advanced knowledge of country/region Regulatory Agency (RA), Central Ethics Committee (CEC), and other country-level authority clinical trial requirements, as applicable.
* Inputs to strategic planning of submissions to RA, CEC, and other country-level bodies, including proactive identification and mitigation of risks, as applicable.
* Directly interacts with RA, CEC, and other country-level bodies.
* Ensures timely preparation/creation/adaptation/coordination/collation of submission pack/documentation according to applicable requirements.
* Arranges internal/external review of submission/documentation according to project requirements.
* Tracks and files central submission/approval progress in Clinical Trials Management System (CTMS), eTMF, and other applicable systems ensuring accuracy and completeness of data/documents entered.
* Performs translation management according to project requirements.
* Ensures project team is informed of applicable clinical trial Regulatory submissions and approvals in accordance with project requirements.
* Collaborates with other roles in-country/region to meet company's deliverables.
* Ensures all project-specific training is completed on time, as applicable.
* Adheres to study budget and proactively identifies out-of-scope activities.
* Supports the surveillance, collection, and maintenance of accurate, up-to-date clinical trial global/regional/country and regulatory clinical trial intelligence.
* May mentor junior team members.
* May contribute to the review of company systems and procedures as appropriate.
* Any other duties deemed necessary to secure the success of company's business.
Requirements:
* Minimum of 3 years' relevant regulatory experience.
* Read, write, and speak fluent English.
* Recognize, exemplify, and adhere to company values which centre around commitment to people, clients, and performance.
* As a member of staff, the employee is expected to embrace and contribute to culture of process improvement with focus on streamlining processes adding value to business and meeting client needs.
Benefits:
* A range of health insurance offerings to suit your needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for years ahead.
* Global Employee Assistance Programme offering 24-hour access to network of over 80,000 independent professionals who are there to support you and your family's well-being.
* Life assurance.
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
About Us:
We pride ourselves on fostering an inclusive environment driving innovation and excellence. We welcome talented individuals to join us on our mission to shape the future of clinical development.