Life Sciences Regulatory Services Associate Manager

LifeScience Regulatory Svs Assoc Manager

Skill required: Regulatory Services - Life Sciences Regulatory Operations
Designation: LifeScience Regulatory Svs Assoc Manager
Qualifications:MSc
Years of Experience:10 to 14 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. 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? •Ability to establish strong client relationship •Ability to handle disputes •Ability to manage multiple stakeholders •Ability to meet deadlines •Ability to perform under pressure
Roles and Responsibilities: •In this role you are required to do analysis and solving of moderately complex problems • Typically creates new solutions, leveraging and, where needed, adapting existing methods and procedures • The person requires understanding of the strategic direction set by senior management as it relates to team goals • Primary upward interaction is with direct supervisor or team leads • Generally interacts with peers and/or management levels at a client and/or within Accenture • The person should require minimal guidance when determining methods and procedures on new assignments • Decisions often impact the team in which they reside and occasionally impact other teams • Individual would manage medium-small sized 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