Regulatory Excellence Center Experts and Senior Specialists

Posted 05 Feb 2020

Bangalore SBS, Karnataka - India

Req Id 203011

Details

A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Our company will be looking for several Expert and Senior Specialist positions for our newly established Regulatory Excellence Center in Bangalore.

The Regulatory Excellence Center will be a unique platform within the Global Regulatory Affairs, powering our integrated execution.

 

EDUCATION:

We seek applicants with minimum MSc degree in a Life Science or a related discipline, higher degree is preferable (e.g. PhD in a scientific discipline).

  

EXPERIENCE:

6-9 years of pharmaceutical industry experience, with at least 3 years in the Regulatory Affairs area

 

COMPLEXITY:

Both Expert and Senior Specialist roles will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. Positions will provide an exposure to a communication with external stakeholders as well (i.e. CMOs, Vendors, Health Authorities). Experts and Senior Specialist will have to work on complex tasks and to propose solutions and strategies as part of their day to day work.

 

ACCOUNTABILITY and INDEPENDENCE:

Each role will be set clear expectations to the own accountability, the interdependencies and strict criteria on the quality of the own deliverables. In addition, the Experts and the Senior Specialists will usually be accountable for the assigned project/product team deliverables and will guide the assigned teams accordingly. The roles will not have people management responsibilities.

 

JOB SPECIFIC COMPETENCIES AND SKILLS

  • Experience in preparation and management of regulatory documentation, including new product applications and large variations
  • Excellent knowledge of global pharmaceutical legislation
  • Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)
  • Practical experience in one of the following areas for small or for biotech molecules: submission project management, CMC, Labelling and artworks, including authoring of some parts of the dossier, preparation of answers to HA questions, PV, QA
  • Ability to develop and prepare successful regulatory strategies and dossiers
  • Awareness of regulatory affairs contribution to Pharma business
  • Hands on experience with various Regulatory IT applications: DMS, RIM systems, Publishing and validation tools, e-portals
  • Hands on experience with various MS applications: Word, Excel, Power point, SharePoint, Outlook
  • Excellent Project management/ Submission project management
  • Ability to plan and organize the own workload and tasks, as well the work of the assigned project team
  • Excellent written and spoken communication skills in English
  • Very good interpersonal skills and flexible mindset
  • Attention to details, including capability to perform quality checks on the deliverables of the junior team members or of the assigned project team
  • Ability to drive the team work
  • Desire to learn and develop, as well to support the junior team members in their learning and development
  • Ability to think strategically, to perform root cause analysis and to propose and drive continuous improvement

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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