GRLI-0, Senior Specialist Licence Management

Job description

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

Our 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 Veeva Vault Registration module 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: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture.  You can also apply and find more information at https://jobs.vibrantm.com

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

Job Requisition ID:  247464

Location:  Bangalore

Career Level:  D - Professional (4-9 years)

Working time model:  full-time .buttontext3e34be14e841299e a{ border: 1px solid transparent; } .buttontext3e34be14e841299e a:focus{ border: 1px dashed #eb3c96 !important; outline: none !important; }

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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