Job Description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you\'ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people\'s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

Role:

The Specialist Licence Management prepares 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 4 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

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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

Job Requisition ID: 266226

Location: Bangalore

Career Level: C - Professional (1-3 years)

Working time model: full-time

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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Merck Group