Expiry Date: 06-11-2021
Category Regulatory Affairs
Job Type: Full Time
Regulatory Affairs US Labelling Strategist (Snr Mgr or Associate Director) - Strategic Labelling Role!
We have a great opportunity for a Regulatory Affairs Labelling specialist to move into an exciting and expansive strategic labelling role covering both development and lifecycle products.
Locations are varied, and this role can be covered from Atlanta, Georgia or RTP, North Carolina or Cambridge, Massachusetts with options also available for home working.
You will own the development, review, approval, and maintenance of labeling for designated products and lead the Cross Functional Labeling Team, managing major US labeling projects & initiatives. You will also be participating in the development of the labeling objectives early in product development to assist teams in creating development strategies and working in conjunction with regional leads, representing regional and local perspective during the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS).
My client is passionate about science and innovation, and they are looking for passion and innovation in their regulatory leadership positions as well. They have a strong pipeline and a good number of new innovative product launches planned over the next 3-5 years and are also involved in developing Gene Therapy products, so it’s an exciting time to join as the future looks extremely positive. As well, they have a number of global blockbuster (marketed) products in both Immunology and Neurology across both small and lager molecules.
Ideal candidates will have extensive regulatory labelling experience coupled with a proven track record of strategic agility and proven experience with engagement and relationship building within your current organisation. You will also need excellent communication and influencing skills plus proven experience with line management with a Life Sciences degree or equivalent.
If you are interested in applying for this role or wish to call me to discuss the role in more details please call (Theo Moore) on 855 505 1382 or email me via Theo@AdvTalent.com. Alternatively, please press the red “Apply for position” button and follow the registration process.
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