Regulatory Affairs - Senior Manager-English - Remote UK

Job Description - Regulatory Affairs-Senior Manager- English-Remote UK (LIF019471)

Inviting applications for the role of Regulatory Affairs-Senior Manager- English-Remote UK

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients.

We are looking for an experienced candidate with deep expertise in navigating customers through complex software implementation. Veeva’s Vault RIM suite is the industry’s 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 cloud-based platform.

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 cloud-based solution for managing regulatory information across the enterprise.

Responsibilities

• Lead software implementation projects at life sciences companies ranging from the world's 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 cross-functional 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
• In-depth 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

• Bachelor's 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
• Execution experience with Agile methodology and/or ACP Certification
• Life Science, computer science or related degree
• Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)

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 trainings and great career development opportunities

·Free access to our award-winning 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 diversity and inclusion, respect and integrity, customer focus, and innovation.

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