Position Details: Domain Consultant Regulatory Affairs

Job Description :   

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 

Responsibilities

• 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 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 intellectual capital repository.

Qualification

• 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

2) Location for the position  NJ

3) Will any of these positions have any employees reporting into them? If so, please provide the employee numbers  No