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Kaztronix
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Director, Regulatory Affairs CMC - Biologics
Iselin, NJ US
Job Description
Qualifications
A minimum ten (10) years of industry / regulatory experience (5 years with an advanced degree) in pharmaceutical, medical device or combination product research, development and/or manufacturing
Experience in CMC regulatory (IND, CTA, BLA, MAA) with a drug-device product
Demonstrated sound understanding of related fields (e.G., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are 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
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills
Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
Strong knowledge and understanding of design controls process
Demonstrated effective leadership, communication, interpersonal and negotiating skills in particular with cross functional partners and health authorities
Responsibilities
Under direction from Executive Director, the Director will be responsible for implementing Devices and Drug-Device Combinations (DDDC) regulatory strategies for our organization in accordance with domestic and international regulations and guidance
Responsible for the preparation and submission of combination product sections for commercial or new products such as pre-filled syringes and autoinjectors
Lead the development and the implementation of regulatory strategies for their assigned projects and provide mentoring and coaching as required
Maintain in depth knowledge of global device and drug/biologic-device combination product guidelines and policy regarding IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE markings
Serve as a Regulatory Project Lead and provide Regulatory leadership within Regulatory and on cross-functional teams for the assigned device and combination products in development or commercial products
Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for submission and approval of complex INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, and responses to health authority questions according to defined timelines
Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions
Resolve complex project issues through collaboration with the team and cross functional partners and provide recommendations to Regulatory leadership team as appropriate
Collaborate with Device Development, Device Quality, and other Drug stakeholders to communicate and align on new regulations and requirements to ensure internal procedures and processes are compliant for the combination product
Participate in activities and teams related to device and combination products
Support device design control activities and documentation reviews
Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence of potential suppliers, partners, or acquisitions
Careful planning, tracking, and communicating regarding submissions and approvals to support continued product supply
Participation in early and late development programs, as well as departmental and cross-functional efforts to improve combination product content or processes may also be required, as needed
May need to manage or mentor junior team members
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
A minimum ten (10) years of industry / regulatory experience (5 years with an advanced degree) in pharmaceutical, medical device or combination product research, development and/or manufacturing
Experience in CMC regulatory (IND, CTA, BLA, MAA) with a drug-device product
Demonstrated sound understanding of related fields (e.G., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are 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
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills
Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
Strong knowledge and understanding of design controls process
Demonstrated effective leadership, communication, interpersonal and negotiating skills in particular with cross functional partners and health authorities
Responsibilities
Under direction from Executive Director, the Director will be responsible for implementing Devices and Drug-Device Combinations (DDDC) regulatory strategies for our organization in accordance with domestic and international regulations and guidance
Responsible for the preparation and submission of combination product sections for commercial or new products such as pre-filled syringes and autoinjectors
Lead the development and the implementation of regulatory strategies for their assigned projects and provide mentoring and coaching as required
Maintain in depth knowledge of global device and drug/biologic-device combination product guidelines and policy regarding IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE markings
Serve as a Regulatory Project Lead and provide Regulatory leadership within Regulatory and on cross-functional teams for the assigned device and combination products in development or commercial products
Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for submission and approval of complex INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, and responses to health authority questions according to defined timelines
Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions
Resolve complex project issues through collaboration with the team and cross functional partners and provide recommendations to Regulatory leadership team as appropriate
Collaborate with Device Development, Device Quality, and other Drug stakeholders to communicate and align on new regulations and requirements to ensure internal procedures and processes are compliant for the combination product
Participate in activities and teams related to device and combination products
Support device design control activities and documentation reviews
Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence of potential suppliers, partners, or acquisitions
Careful planning, tracking, and communicating regarding submissions and approvals to support continued product supply
Participation in early and late development programs, as well as departmental and cross-functional efforts to improve combination product content or processes may also be required, as needed
May need to manage or mentor junior team members
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
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