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ARM Life Sciences are looking for a Regulatory Affairs Manager to join their client based in Lincolnton, North Carolina. My client are a generic pharmaceutical company specialising in the areas of dermatology and allergy.
My client are a fully integrated generic pharmaceutical company with end to capabilities in product development, manufacturing and commercials operations. With a well-established R&D and business development function, they are expanding their products range by offering to bring new products to market via internal development, external licencing and acquisitions.
This is a highly visible Regulatory role with exposure to manufacturing operations, internal development as well as 3rd party development projects. You will work closely with R&D and manufacturing operation teams to provide regulatory strategy, prepare, review and submit regulatory filing documents, monitors and tracks information and requirement changes and maintains interactions with regulatory agencies. The structure of this business is fairly flat with good rates of progression within the first 12 months. Working for a small company of just over 200 you will be given the opportunity to add value to the business as well progress your own career with further development plans in the business already in process.
You will have experience within Regulatory Affairs in providing regulatory Strategy, compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) submissions. Experience with the Common Technical Document (CTD) format and electronic publishing experience is highly desired (eCTD). Experience with labeling and FDA compliance requirements required. .
· Provide regional Regulatory strategy to manufacturing sites, R&D teams and Commercial teams for Complex NDA/ANDA/OTC formulations.
· Represents Regulatory Affairs on cross-functional project teams.
· Coordinate, assemble and/or prepare, high quality US regulatory submissions to expedite approval and sustain commercial availability for all products.
· Interact with regulatory agencies as required in a timely and appropriate manner to respond to any questions during the review process.
· Review and approve change controls for potential impact on regulatory status.
· Participate and represent Regulatory in meetings and interact with members of all development project teams to convey regulatory requirements and develop a strategy to meet divisional goals.
IF you are interested in this role please contact Vik Patel at Advanced Resource Managers on +442392 458031 or email me on email@example.com
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