Senior Expert/ Expert/ Senior Specialist Licence Management

Posted 04 Sep 2020

Bangalore SBS, Karnataka - India

Req Id 209466

Details

A career at our company is an ongoing journey of discovery: our 57,000 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.


Your Role:

The Expert Licence Management prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the license management strategy and approach.

 

Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will have to work on complex tasks and to propose solutions and strategies as part of their day to day work.

 

Who You Are:

Experience: Minimum 9 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 3 years of Regulatory affairs experience.

Education:

Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)

Job Specific Competencies & Skills:

Ability to contribute to the dossier content and to perform content and quality review on regulatory documentation

Ability to develop and prepare successful regulatory strategies and dossiers

Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations

Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)

Solid experience in Regulatory Affairs regulatory dossiers and regulatory procedures on a global scale, including submission/registrations types and related requirements

In Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc.) and LCM strategies

Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request

Strong project management and documentation skills, proactive communication approach

Ability to execute appropriate risk assessment and mitigation in cooperation with line manager /team lead

Ability to provide Regulatory expertise into the planning and execution of projects and tasks

Ability to work within a matrix organisation, build relationships with internal or external stakeholder

Contributor level experience with RIM and EDMS RA applications

Excellent written and spoken communication skills and English language knowledge

 

Job Location:

Electronic City Phase 1 - Bangalore

 

We have several openings for License Management roles for various levels and profiles

Expectations and scope of responsibilities provided in this Job posting are for Specialist level

The exact designation to be offered will depend on applicants’ experience and knowledge confirmed during the screening process


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

We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

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