LifeScience Regulatory Svs Specialist

 About The Role  

Skill required: Regulatory Services - Life Sciences Regulatory Operations

Designation: LifeScience Regulatory Svs Specialist

Qualifications:Bachelor of Pharmacy

Years of Experience:7 to 11 years

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.Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc.

What are we looking for? Raising this demand to claim Productivity benefit stay within dealRaising this demand to claim Productivity benefit stay within deal

Roles and Responsibilities: ?¢In this role you are required to do analysis and solving of moderately complex problems?¢ May create new solutions, leveraging and, where needed, adapting existing methods and procedures?¢ The person would require understanding of the strategic direction set by senior management as it relates to team goals?¢ Primary upward interaction is with direct supervisor?¢ May interact with peers and/or management levels at a client and/or within Accenture?¢ Guidance would be provided when determining methods and procedures on new assignments?¢ Decisions made by you will often impact the team in which they reside?¢ Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture?¢ Please note that this role may require you to work in rotational shifts
 Qualification Bachelor of Pharmacy