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Regulatory Affairs Systems & Operations Services Manager

Begin a meaningful career right here.
 
Are you passionate about solving tough challenges? In this role you will use your skills to find creative solutions for consumer's everyday problems! If this sounds like fun, we would love to hire someone with your skills and abilities to join our R&D organization.
 
This role operationalize Regulatory Affairs Information Management, Dossier Authoring, Publishing Services, and provides user support and training. During this last year P&G merged multiple global health care businesses together and consequently fully re-built a central regulatory operations team, with state of the art systems and full range of global regulatory services including: Administration of Veeva Information Systems; Publishing and Archival Services; Centralized Dossier and document template management; Lead operational improvement projects; training and support for new users. These Regulatory Operations Service are now expanding to include US FDA submissions and authorizations.
 
Key Responsibilities Include:
 
    * Function as a Business Admin for Veeva RegulatoryOne (Regulatory Information Management System).
    * Work with routine publishing team to complete FDA/Global submission.
    * Administer eCTD based content plans templates and doc templates in Veeva Regulatory One.
    * Liaison with Oral Care and Personal Health Care technical content owners, medical writers, and Regulatory Managers.
    * Learn and provide training to new users.
    * Execute and test operational and systems improvement projects in Regulatory Affairs.
 
 
We are looking for someone with a Bachelor or Master degree in the field of Life Science - Biology, Biochemistry, Microbiology, Pharmacy, clinical research or related field required.
 
Technical Mastery:
    * Regulatory Affairs experience with eCTD dossier authoring and publishing.
    * Strong grasp of submission/publishing processes and requirements, templates, and best practices.
    * A minimum of 3 years proven experience in regulatory filings or medical writing for eCTD dossiers i.e. drugs 510K, IND, NDA ,etc. preferably with US FDA.
    * Strong aptitude to use and manage information management systems. Veeva skills/capability a plus.
 
Operates with Discipline:
 
    * Self Starter; Acts with a sense of urgency and bias for action, planning & follow through, and the ability to set priorities.
    * Strong Aptitude for Regulatory Information Systems: Experience in Veeva Platforms, ideally Regone, or other education/experience in using Regulatory Information Systems.
    * Enjoy working with information management systems and advocate for best practices.
 
Communication:
 
    * Excellent communication skills; used to working in a global team environment; communicates plans and progress in a timely manner to stakeholders; seeks to understand first in decision making.
    * Learning and Coaching:
    * Able to absorb new information and processes quickly; in turn provide knowledge transfer to others, and trouble shoot technical gaps; Be seen as an expert in the organization.
 
What we offer:
 
Responsibilities as of Day 1 – you will feel the ownership of your project from the beginning, and you will be given specific projects and responsibilities.
 
Continuous mentorship – you will work with passionate people and receive both formal training as well as day-to-day mentoring from your manager.
 
Work and be part of a dynamic and encouraging environment - working over a diverse array of interesting problems.
 
Promote agility and work/life balance for employees, we value every individual and support initiatives, promoting.
 
We love flexibility. You can arrange your work schedule based on your personal needs.
 
Experience true support for work/life effectiveness and your long-term well-being.
 
Get a competitive salary and benefits' package.
 
About us
 
We produce globally recognized brands, and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Oral-B®, Pampers®, Pantene®, Tampax® and more. Our community includes operations in approximately 70 countries worldwide.
 
Visit http://www.pg.com to know more.
 
Our consumers are diverse and our talents - internally - mirror this diversity to best serve it. That is why we’re committed to building a winning culture based on Inclusion and our ideal candidate is passionate about the same principle: you will join our daily effort of being “in touch” so we craft brands and products to improve the lives of the world’s consumers now and in the future. We want you to inspire us with your unrivaled ideas.
 
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, citizenship, HIV/AIDS status or any other legally protected factor.
 
Immigration sponsorship is not available for this role. As a general matter, 
 
Procter & Gamble does not sponsor candidates for nonimmigrant visas or permanent residency. However, Procter & Gamble may make exceptions on a discretionary basis. Any exceptions would be based on the Company's specific business needs at the time and place of recruitment as well as the particular qualifications of the individual.
 
Procter & Gamble participates in e-verify as required by law.
 
Qualified individuals will not be disadvantaged based on being unemployed.rly detai