Senior Global Regulatory Scientist

Senior Global Regulatory Scientist- Office based- India ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Job Description:

• Minimum 3 years’ relevant regulatory experience • Read, write and speak fluent English • Travel less than 10% • Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs • Ensure regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles • Manage regulatory deliverables independently including complex studies with some oversight from leadership • Advanced knowledge of ICON’s SOPs/WIs, ICH, GCP and appropriate regulations • Advanced knowledge of ICON systems applicable to role • Regulatory functional team lead, overseeing the assigned clinical trial regulatory project team • Development of overall and global clinical trial submission strategy according to project requirements in collaboration with stakeholders • Preparation/development/review/finalisation of regulatory plan according to project requirements • Prepare/create/adapt/coordinate/collate/review core documentation considering strategic, scientific and therapeutic area principles in addition to study requirements • Attend internal and external project team meetings representing Regulatory • Coordinates clinical trial submission(s) to regulatory agencies (RAs), central ethics committees (CECs), and all other country-level submissions according to project requirements • Ensure accuracy and completeness of data/documents entered into relevant systems • Ensure project team is informed of regulatory status in accordance with project requirements • Ensure all project-specific training is completed on time • Manages regulatory study budget and contracted scope, proactively identifies out of scope activities and supports forecasting and recognition of regulatory deliverables Represents Regulatory during project audits providing responses to queries to a satisfactory outcome, under the oversight of leadership • Represents Regulatory during project CAPAs providing input to a satisfactory outcome, under the oversight of leadership • Represents Regulatory during the request for proposal process providing strategic input and budget review with some oversight from leadership • Represents Regulatory during Bid Defence meetings providing strategic and operational input with some oversight from leadership • Supports the surveillance, collection, and maintenance of accurate, up-to-date clinical trial global/regional/country and regulatory clinical trial intelligence • Participates in initiatives, as deemed necessary by Regulatory leadership • May mentor junior team members • May contribute to the review of ICON systems and procedures as appropriate • Any other duties deemed necessary to secure the success of ICON’s business

Job Responsibilities:

• Ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles • Developing the overall and global clinical trial submission strategy in accordance with the project requirements in collaboration with stakeholders including proactive identification and mitigation of risks, as applicable • Regulatory function team lead overseeing the assigned clinical trial Regulatory project team • Point of contact for clients for clinical trial Regulatory deliverables • Preparation of clinical trial Regulatory plan in accordance with project specifications •Preparation/creation/adaptation/coordination/collation/compliance of global core documents considering strategic, scientific and therapeutic area principles in addition to study requirements • Tracking and reporting of submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents • Performing Quality Control review of clinical trial Regulatory deliverables in accordance with applicable process • Coordinating submission(s) to regulatory agencies (RAs), central ethics committees (CECs), and all other country-level submissions in collaboration with stakeholders, overseeing the assigned Regulatory project team • Coordination of clinical trial label review/approval according to project specifications • Managing Regulatory study budget, proactively identifying out of scope activities and supporting budget recognition • Supporting the maintenance of accurate, up to date Country and Regulatory Intelligence • May work with Regulatory team members to provide Regulatory consulting services • May participate in business development activities • May participate in initiatives • May mentor junior team members • May contribute to the review of ICON systems and procedures, as appropriate • Any other duties deemed necessary to secure the success of ICON’s business

Job Requirements:

• BSc degree in a scientific field. • 3-6 years’ relevant global regulatory experience in clinical trials for pharmaceuticals. • Good communications and client-facing skills. • Adaptive personality with an agile mindset. • Fluent English.

#LI-Remote #LI-Onsite #LI-Hybrid #LI-MK2

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request  here .

Are you a current ICON Employee? Please click here to apply