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Director, Regulatory Affairs
* Performs regulatory strategic analysis (planning, development & delivery)
* Displays a strong ability to lead and direct interdisciplinary teams for regulatory activities
* Strongly connected and versed in regulatory systems use such as
* Publishing systems, Word, Visio, Excel
* Strong attention to detail along with problem solving, organizational and decision-making skills.
* Exceptional regulatory communication skills including extensive experience with representing regulatory strategy to competent authorities, development teams and senior leadership
* Comfortable working in a fast-changing, evolving environment
* Able to effectively work independently and within small groups in an entrepreneurial, development environment
* Deep experience in managing regulatory vendors for large global submissions such as publishers, medical writers, data managers and auditors
* Excellent written, verbal, and interpersonal communication skills and a collaborative working style.
* Pursues team alignment with regulatory strategy
* Effectively resources regulatory activities with plans, structures and processes for large global regulatory submissions.
* Plans, develops and delivers regulatory documents that meet appropriate laws and regulations and coordinates with global MDCO colleagues.
* Creates strong network and interdependencies across all teams within MDCO especially with Development Teams, quality and compliance.
* Measures output against goals
* Ensures regulatory activities are on time and on budget
* Ensure that all materials align with MDCO quality standards (i.e. Global Code of Conduct) and messaging is compliant with all external laws and regulations.
* Skilled in writing regulatory submissions utilizing appropriate technical terminology nd regulatory and medical style guides.
* Extensive experience managing global regulatory activities in a pharmaceutical and/or medical device company
* Extensive technical expertise in chemistry, manufacturing and control (CMC) and device regulatory and quality systems
* Minimum of 8-10 years Regulatory Affairs experience in the pharmaceutical and/or medical device industry
* Experience with electronic publishing operations and medical writing
* Experience with publishing of large global regulatory submissions with emphasis in CMC and quality.
* Submission experience and expertise in small molecule pharmaceuticals, medical devices and drug delivery technology
* BS in Science Discipline or equivalent hands-on experience
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