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Senior Regulatory Affairs Manager
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.
•Update Allergopharma RA on significant changes of regulations or new regulations issued by the regulatory authorities,
•Analyze impact of regulatory environment change on BU business and propose actions which Allergopharma RA needs to take
•Fulfill RA responsibility for BU business
•Develop and implement registration strategy and plan for new products in align with BU growth strategy
•Ensure validation of existing products in terms of license, variation, labeling and packaging without impact on BU business in a timely manner
•Keep a good communication with the regulatory authorities to ensure any regulatory application of BU to obtain an optimal results and timely feedback on the request from regulatory authorities
•Set up process & infrastructure for documentation, dossier preparation and information provided to regulatory authorities as request
•As RA role, contribute to the company systems development such as SOPs, working procedures etc. to ensure operational efficiency.
Who you are:
•Minimum of 7 years regulatory experience in the pharmaceutical or biotech industry
•Excellent understanding of local regulations, guidelines and requirements
•Proven expertise in preparing or managing regulatory submissions and achieving approvals
•Demonstrated experience in interaction with regulatory authorities
Functional Area: Regulatory & Medical Affairs
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