LifeScience Regulatory Svs Specialist

LifeScience Regulatory Svs Specialist

Skill required: Regulatory Services - Life Sciences Regulatory Affairs
Designation: LifeScience Regulatory Svs Specialist
Qualifications:Bachelor of Pharmacy
Years of Experience:7 to 11 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s 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. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Regulatory Services involves helping organizations comply with laws and regulations. This role includes providing guidance on regulatory requirements, preparing necessary documentation, and submitting reports to regulatory authorities. It also involves staying updated on regulatory changes and conducting compliance audits. The goal is to ensure the organization meets all legal and regulatory obligations efficiently. Collect, 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? •Adaptable and flexible •Ability to perform under pressure •Problem-solving skills •Detail orientation •Ability to establish strong client relationship
Roles and Responsibilities: Gather, review, analyze, and evaluate pertinent data to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: clinical study reports (CSRs), patient narratives, protocols, investigator’s brochures, CTD Modules, DSURs, PBRERs, PADERs, etc. The tasks, to a large extent, will have to be performed independently.