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Full-time
postgraduate degree
Posted 4d ago
~40 hrs/week
Responsibilities
The manager will oversee regulatory submission strategies, author CMC documents, and ensure organizational compliance with legal and scientific requirements. They are responsible for gathering, analyzing, and finalizing clinical documents such as CSRs, protocols, and safety reports for submission to regulatory authorities.
Requirements
Candidates must possess an MSc degree and have 13 to 18 years of relevant experience in life sciences regulatory affairs. Strong analytical skills, the ability to perform under pressure, and experience in regulatory documentation and compliance are required.
Full job description
Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Manager Qualifications:MSc Years of Experience:13 to 18 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.MSc
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.
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, militaryveteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by applicablelaw. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.
Related keywords
Regulatory AffairsLife SciencesAccentureClinical TrialsPharmacovigilanceRegulatory ComplianceCMCCSRCTD ModulesDSURPBRERPADERRegulatory SubmissionR&DCompliance AuditsScientific Data
Accenture helps the world’s leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed for organizations across industries. Our strategy is to be the reinvention partner of choice for our clients and lead in the safe, widespread adoption of AI, and to be the most client-focused, AI-enabled, great place to work in the world. We bring together the talent of our approximately 786,000 people with proprietary assets and platforms, deep process and industry expertise, and leading ecosystem relationships to deliver end-to-end solutions and measurable outcomes at scale. Through our Reinvention Services, we offer broad expertise across Cybersecurity, Digital Core, Finance, Industry and Enterprise, Song, Supply Chain and Engineering, and Talent, with advanced capabilities in AI and Data, Industry and Process, and Technology. We serve approximately 9,000 clients and generated approximately $70 billion in FY25 revenue. Visit us at accenture.com.
This LinkedIn company page is moderated. When engaging with Accenture, we encourage everyone to:
- Use common courtesy and be respectful of others.
- Create your own original content and avoid content that you know to be fraudulent.
- Never repost someone else's copyrighted work, unless you have permission.
- Never post personal, identifying, or confidential information.
We reserve the right to delete comments or posts we deem to be:
- Profane, obscene, inappropriate, offensive, abusive material.
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Offices: Grand Canal Harbour, Dublin 2, IE · 415 Mission Street, Floor 31-34, San Francisco, California 94105, US · Porkkalankatu 5, Helsinki, Southern Finland 00180, FI · Level 29 & 30, Menara Exchange 106, Lingkaran TRX, Tun Razak Exchange, Kuala Lumpur, Kuala Lumpur 55188, MY · Warsaw Towers Sienna 39, Warsaw, 00-121, PL
Management ConsultingSystems Integration and TechnologyBusiness Process Outsourcingand Application and Infrastructure OutsourcingInfrastructureData ManagementSoftwareOutsourcingManufacturingConstruction
Accenture helps the world’s leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed for organizations across industries. Our strategy is to be the reinvention partner of choice for our clients and lead in the safe, widespread adoption of AI, and to be the most client-focused, AI-enabled, great place to work in the world. We bring together the talent of our approximately 786,000 people with proprietary assets and platforms, deep process and industry expertise, and leading ecosystem relationships to deliver end-to-end solutions and measurable outcomes at scale. Through our Reinvention Services, we offer broad expertise across Cybersecurity, Digital Core, Finance, Industry and Enterprise, Song, Supply Chain and Engineering, and Talent, with advanced capabilities in AI and Data, Industry and Process, and Technology. We serve approximately 9,000 clients and generated approximately $70 billion in FY25 revenue. Visit us at accenture.com.
This LinkedIn company page is moderated. When engaging with Accenture, we encourage everyone to:
- Use common courtesy and be respectful of others.
- Create your own original content and avoid content that you know to be fraudulent.
- Never repost someone else's copyrighted work, unless you have permission.
- Never post personal, identifying, or confidential information.
We reserve the right to delete comments or posts we deem to be:
- Profane, obscene, inappropriate, offensive, abusive material.
- Spam, repeated comments and commercial messages and personal advertisements.
- Discriminatory or that contain hateful speech of any kind regarding age, gender, race, religion, nationality, sexual orientation, gender identity or disability.
- Threats; personal attacks; abusive, defamatory, derogatory, or inflammatory language; or stalking or harassment of any individual, entity or organization.
- False, inaccurate, libelous, or otherwise misleading in any way.
Offices: Grand Canal Harbour, Dublin 2, IE · 415 Mission Street, Floor 31-34, San Francisco, California 94105, US · Porkkalankatu 5, Helsinki, Southern Finland 00180, FI · Level 29 & 30, Menara Exchange 106, Lingkaran TRX, Tun Razak Exchange, Kuala Lumpur, Kuala Lumpur 55188, MY · Warsaw Towers Sienna 39, Warsaw, 00-121, PL
Management ConsultingSystems Integration and TechnologyBusiness Process Outsourcingand Application and Infrastructure OutsourcingInfrastructureData ManagementSoftwareOutsourcingManufacturingConstruction