Regulatory Affairs-Senior Manager- English-Remote UK
Regulatory Affairs-Senior Manager- English-Remote UK
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Job Description
Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125000 people across 30 countries are driven by our innate curiosity entrepreneurial agility and desire to create lasting value for clients. Powered by our purpose the relentless pursuit of a world that works better for people we serve and transform leading enterprises including the Fortune Global 500 with our deep business and industry knowledge digital operations services and expertise in data technology and AI.
Inviting applications for the role of Regulatory AffairsSenior Manager EnglishRemote UK
We are looking for an experienced candidate with deep expertise in navigating customers through complex software implementation. Veevas Vault RIMsuite is the industrys only unified software solution that provides fully integrated regulatory information management (RIM) capabilities including data and document management submission publishing and archival on a single cloudbased platform.
Veeva Systems is looking for consulting leaders with system implementation experience and a passion for helping customers optimize their regulatory data and document management processes.
As a key member of our Professional Services team the candidate will be responsible for understanding our customers global regulatory needs translating requirements into solution design and defining global strategies for deploying our cloudbased solution for managing regulatory information across the enterprise.
Responsibilities
- Lead software implementation projects at life sciences companies ranging from the worlds largest pharmaceutical companies to emerging biotechs
- Lead the solution design for implementation and use of the Vault Regulatory suite (Vault Registrations Vault Submissions Vault Submissions Archive Vault Publishing)
- Lead configuration requirements workshops design prototype configure and document content solutions
- Program and project management including resource planning leading and motivating a crossfunctional team
- Primary customer liaison managing communication between the project team customer and internal stakeholders
- Mentor project team and consultants helping others improve their consulting skills
- Good years experience working with life sciences or healthcare companies performing system implementation experience either as a consultant business or IT representative
- Indepth knowledge of drug development processes and regulatory submissions; including Labeling Submission Publishing and/or Viewing systems
- Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction
- Influential; experience leading teams through hard decisions and negotiating compromises
- Technical abilities and willingness to roll up your sleeves to design and implement a RIM solution
- Expert on life sciences compliance and computer systems validation requirements
- Ability to work independently in a dynamic environment
- Typical travel is 25 but may be up to 50 based on customer requirements
Qualifications we seek in you!
Minimum Qualifications / Skills
- Bachelors degree required in science engineering or related field (advanced degree preferred)
Preferred Qualifications/ Skills
- Direct experience with systems such as Veeva Vault PAREXEL/LIQUENT InSight CSC Regulatory Tracker ArisGlobal Register OpenText SharePoint Documentum FirstDoc/FirstPoint NextDocs CARA Salesforce Workday Oracle SAP Lorenz Docubridge Extedo eCTD Manager Master Control Trackwise other regulatory information management or submission publishing systems etc.
- Consulting experience working with a major system integrator or software vendor
- Regulatory Affairs Regulatory Operations or Pharmacovigilance background
- Knowledge of Pharmaceutical Biotechnology and/or Medical Device and Diagnostics regulatory processes data and content
- PMP certification
- experience with Agile methodology and/or ACP Certification
- Life Science computer science or related degree
- SaaS/Cloud experience
- Locality to major life sciences customer hub (NJ; Boston MA; San Francisco CA; Philadelphia PA; Chicago IL)
- English Fluency
What can we offer
Attractive salary;
Stable job offers employment contract
Work in a multicultural and diverse environment with employees from over 30 countries
Genpact supports professional tranings and great career development opportunities
Free access to our awardwinning learning platform
Benefits such as Meal Tickets Medical Services Insurance additional vacation days or partner discounts
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race color religion or belief sex age national origin citizenship status marital status military/veteran status genetic information sexual orientation gender identity physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity customer focus and innovation. Get to know us at www.genpact and on X Facebook LinkedIn and YouTube.
Furthermore please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a starter kit paying to apply or purchasing equipment or training.
Required Experience:
Senior Manager
Employment Type
Full-Time
