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ARM Life Sciences have recently partnered with a leading global Pharma/Biopharma client based in North New Jersey who are looking for a program support to strengthen their CMC departments.
The purpose of this role would be to be responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical device/instruments in accordance with global regulations and guidance’s, and client's procedures. The Associate Director will lead the preparation and submission of CMC dossiers for life-cycle changes to commercial devices. The Associate Director may manage a team of 2 to 4 individual contributors in support of project execution.
Other responsibilities will include the following –
· Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the device/instrument lifecycle.
· Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
· Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements.
· Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
· Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
· Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
Required Qualifications "
· Strong experience in CMC requirements for small molecule/biologic products.
· Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
· Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
· Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
· Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
This is an interesting time with the global pandemic but having been in the industry for 12 years, I am well placed to advise you in respect of your career and keep you updated with trends I see with numerous candidates I place in these role. These contracts are either on 6 or 12 months project with good scope for extension.
If you are interested in hearing or more if you want to speak about this current market, please email me on email@example.com
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