Role at a glance
- Job function
-
Legal & Compliance Compliance & Regulatory Affairs
- Salary
- Not Disclosed
- Location
- Bengaluru, BDC9A
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- 1 to 3 years
- Education
- Master of Pharmacy
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Role Summary
The LifeScience Regulatory Svs Associate performs life sciences regulatory operations and supports regulatory submissions. The role involves preparing and reviewing submission components, evaluating scientific data, and supporting compliance with current regulations and health authority requirements.
What You'll Do
- Bookmark and hyperlink granular components of submission documents in accordance with ICH guidelines and health authority requirements.
- Transform source documents and perform quality control checks for submission components.
- Collect, collate, and evaluate scientific data gathered as part of R&D.
- Advise on legal and scientific restraints and requirements.
- Support regulatory submission strategy, CMC document authoring, and health authority packages.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Primary skill: Life Sciences Regulatory Affairs; Master of Pharmacy; 1 to 3 years of experience.
Required
- Life Sciences Regulatory Affairs
- Master of Pharmacy
- 1 to 3 years of experience
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Designation: LifeScience Regulatory Svs Associate
Qualifications:Master of Pharmacy
Years of Experience:1 to 3 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? • Life sciences regulatory activities • The 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 components • 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? • Primary skill - Life Sciences Regulatory Affairs - P1
Roles and Responsibilities: • In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. • Your expected interactions are within your own team and direct supervisor. • You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments. • The decisions that you make would impact your own work. • You will be an individual contributor as a part of a team, with a predetermined, focused scope of work. • Please note that this role may require you to work in rotational shiftsMaster of Pharmacy
About Accenture
Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.Visit us at www.accenture.com
Equal Employment Opportunity Statement
We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, military veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by applicable law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
About the company
Accenture
Large Enterprise
Accenture is a global professional services company that specializes in providing consulting, technology, and outsourcing services. With a diverse range of industries served, including financial services, healthcare, and telecommunications, Accenture leverages advanced technologies and data analytics to help organizations improve their performance and drive innovation. Committed to sustainable progress, the company emphasizes its dedication to inclusivity, digital transformation, and building a more sustainable future for its clients and communities. With a presence in over 120 countries, Accenture is known for its expertise in integrating cutting-edge solutions that address complex business challenges.