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Life Sciences Advisory - Senior Regulatory Domain Consultants
US-NJ-Edison - 08837
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Experienced Life Sciences Domain / Business or Transformation Consultants driving Advisory Services and Delivery, for pharmaceutical and medical devices companies. Provides specific domain expertise and thought leadership across the industry landscape.

More than fifteen years of experience in the Life Sciences (LS) industry (incl. Pharma, Biotech, Medical Devices) Regulatory Affairs with experience in the areas of Regulatory Strategy or Regulatory Development and Regulatory Operations
Strong experience Life Sciences Regulatory areas, with Consulting / Advisory company, Global pharmaceutical or medical devices company / IT Company
For the domain area of expertise above, has a thorough understanding of Business Processes, KPIs, Challenges, and Industry Trends and Regulations
Nice to have: Experience in CMC
Has experience with IT enablement and business transformations, and holistic knowledge of Business and IT Landscape for the domain area of experience above.
Has familiarity with conducting Business Process Reviews, Business Process Improvements, IT Landscape Assessment, IT simplification, driving the adoption of new technology
Experience in developing business aligned IT solutions leveraging latest technologies. Familiar with usual office software plus selected or dedicated (as per focus area above) relevant domain-specific packages
Direct working experience in the LS related industry for a minimum of 5 years
Strong team building skills, strategy, and operations thinking, solution & result orientation, intercultural competence
Excellent verbal and written communication skills
Excellent presentation skills development and delivery
Good public speaking/publishing record
Coaching and mentoring teams with strong domain expertise for global Regulatory processes and operations
Good understanding of life sciences industry global trends, regulations, guidelines, and directives

Drives Advisory opportunity discovery and diagnostics. Helps shape an end state vision for clients' businesses Regulatory Affairs areas
Guides clients in the adoption of leading-edge business processes and best practices; get the best thinking from his/her staff and client team members, in their implementation
Confidently and effectively manages client stakeholders and our client's resources to deliver results
Participates in supporting executive level client Steering Committee meetings; can manage conflict resolution among various stakeholders/staff to successfully support change management initiatives.
Where needed, in an owner or supporter role, drafts proposals, plans phased project execution, develops detailed project plans and manages program budgets and costs; fosters shared accountability for the results-based implementation plan
Facilitates the development of Life Sciences asset advancements by submissions to our client's intellectual capital repository.

PhD / Post Graduation in Sciences or Pharmacy / Engineering Graduate or Post Graduate
MBA is preferred
Questions for Internal and Total Rewards:

1) Years of experience required for position > 15+ years

pratap jiandani
Tephra Inc
1000 Woodbridge Center Drive Suite 144
Suit 720
Woodbridge, US 07095
Phone: 732-636-5000

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