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Specialist Licence Management
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.
The Specialist 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 licence 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 support the resolution of complex tasks, under close supervision and guidance provided from the more experienced License management personnel
Who You Are:
- Minimum 5 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role.
- Minimum 1 year of Regulatory affairs experience
- Degree in a Life Science or a related discipline, preferably MSc
Job Specific Competencies & Skills
- 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)
- Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally
- Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoA’s etc.) as well as legalization framework
- Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request
- Adherence to agreed timelines and proactive communication of any potential risk to the same
- Project management and documentation skills, proactive communication approach
- Contributor level of experience with RIM and EDMS RA applications
- Excellent written and spoken English language
- 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
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of “fully vaccinated” assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.
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.
Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html