LifeScience Regulatory Svs Associate

Skill required: Regulatory Services - Life Sciences Regulatory Affairs
Designation: LifeScience Regulatory Svs Associate
Qualifications:Master of Pharmacy
Years of Experience:1 to 3 years

Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Songall powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries.
What would you do Regulatory Affairs scope of servicesThe incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components documents of submission in accordance with ICH guidelines and other Health Authorities review and transform Source Documents Perform Quality Control Document QC checks for all submission componentsCollect, collate and evaluate the scientific data gathered as part of R D.Advise on legal and scientific restraints and requirements.Ensure the organization s products comply with current regulations.Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc.
What are we looking for Primary skill - Life Sciences Regulatory Affairs - P1
Roles and Responsibilities: Work on end-to-end planning, coordination, compilation, publishing, and dispatch of global regulatory lifecycle submissions across multiple health authorities. Ensure regulatory dossiers and submission packages comply with regional requirements, eCTD standards, and applicable regulatory guidelines. Manage submission timelines, lifecycle activities, renewals, variations, supplements, annual reports, and post-approval regulatory changes. Collaborate with cross-functional stakeholders to track submission readiness, resolve gaps, and support timely health authority interactions and responses. Utilize Regulatory Information Management Systems (RIMS), publishing tools, and quality review processes to deliver compliant, high-quality submissions with on-time execution


Qualification
Master of Pharmacy