LifeScience Regulatory Svs Analyst

Skill required: Regulatory Services - Life Sciences Regulatory Affairs
Designation: LifeScience Regulatory Svs Analyst
Qualifications:Master of Pharmacy
Years of Experience:3 to 5 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 worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 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 worlds 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. The incumbent will perform the regulatory affairs tasks planning and coordination of the Regulatory HA submissions along with building dossiers for multiple TA s in Veeva Vault Systems and other aligned tools You will be expected to 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 regulatory documents, and health authority packages etc.
What are we looking for? Ability to perform under pressure Ability to manage multiple stakeholders Agility for quick learning Collaboration and interpersonal skills Commitment to quality Regulatory Affairs understanding for international markets, Veeva Vault Regulatory Module
Roles and Responsibilities: Responsible for following the procedures which will meet with pre-defined Accenture and /or Roche processes and standards as agreed.