Wise Equation Solutions Inc. · 15 hours ago
Regulatory Affairs Consultant
United States
Contract
Remote
Senior Level, Lead/Staff
10+ years exp
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Hiring Manager
Ravish Khan
Insider Connection @Wise Equation Solutions Inc.
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Responsibilities
Develop global regulatory strategy for lifesaving therapeutic products in development and through life cycle management considering all relevant guidance, commercial needs, and company objectives.
Develop global or US regulatory strategy for therapeutic products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives.
Develop strategic direction and provide leadership for all regulatory interactions with FDA/EMA and global regulatory authorities.
Lead regulatory dossier submissions to FDA (IND, BLA, NDA, and supplements), MAA (EU) utilizing internal and external stakeholders; ensure appropriate quality controls in place for compliant submissions.
Writing regulatory documents (e.g. new BLA/NDA/INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed.
Provide strategic direction (and content input) on US Labeling
Anticipate and interpret key trends and changes in the EMA/US regulatory environment and provide strategic guidance regarding development plans as a result.
Foster positive relationships with FDA.
Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion & Compliance, Global Development, and other functions key to the success of product development.
Interact routinely and will develop a strong team environment with colleagues throughout GRS.
Responsible for implementing CMC regulatory strategies for assigned Biologics specifically for cell gene therapy in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers
Ability to lead client meetings and managing project governance.
Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
Demonstrated ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
Demonstrated effective leadership, communication, and interpersonal skills.
Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals.
Significant experience in regulatory affairs.
Providing leadership in CMC team by directing analytical, DP part of CMC development for multiple product candidates from preclinical to phase 1 clinical development
Expert understanding of policy, laws, regulations, and guidelines as they apply to U.S. FDA and EMA for drug development and approval.
Can represent company for pre-submission meeting with EMA, FDA
Expert understanding of drug development process and understanding of scientific content and complexities related to a project in life-saving therapeutic drugs.
Direct experience in developing strategy and leading teams through interactions with FDA and EMA.
Extensive experience in initiating and conducting successful interactions within FDA.
Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals.
Communicates opinions, facts and thoughts with clarity, transparency, and honesty.
Demonstrates ownership of results within (and beyond) area of responsibility.
Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
Looks for opportunities for continuous improvement.
Qualification
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Required
Ph.D., M.D., PharmD., MS or commensurate experience
Experience level: 10-15 years
Develop global regulatory strategy for lifesaving therapeutic products in development and through life cycle management considering all relevant guidance, commercial needs, and company objectives.
Develop global or US regulatory strategy for therapeutic products in development and through life cycle management, considering all relevant guidance, commercial needs, and company objectives.
Develop strategic direction and provide leadership for all regulatory interactions with FDA/EMA and global regulatory authorities.
Lead regulatory dossier submissions to FDA (IND, BLA, NDA, and supplements), MAA (EU) utilizing internal and external stakeholders; ensure appropriate quality controls in place for compliant submissions.
Writing regulatory documents (e.g. new BLA/NDA/INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed.
Provide strategic direction (and content input) on US Labeling
Anticipate and interpret key trends and changes in the EMA/US regulatory environment and provide strategic guidance regarding development plans as a result.
Foster positive relationships with FDA.
Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion & Compliance, Global Development, and other functions key to the success of product development.
Interact routinely and will develop a strong team environment with colleagues throughout GRS.
Responsible for implementing CMC regulatory strategies for assigned Biologics specifically for cell gene therapy in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers.
Ability to lead client meetings and managing project governance.
Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
Demonstrated ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
Demonstrated effective leadership, communication, and interpersonal skills.
Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals.
Significant experience in regulatory affairs.
Providing leadership in CMC team by directing analytical, DP part of CMC development for multiple product candidates from preclinical to phase 1 clinical development.
Expert understanding of policy, laws, regulations, and guidelines as they apply to U.S. FDA and EMA for drug development and approval.
Can represent company for pre-submission meeting with EMA, FDA.
Expert understanding of drug development process and understanding of scientific content and complexities related to a project in life-saving therapeutic drugs.
Direct experience in developing strategy and leading teams through interactions with FDA and EMA.
Extensive experience in initiating and conducting successful interactions within FDA.
Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals.
Communicates opinions, facts and thoughts with clarity, transparency, and honesty.
Demonstrates ownership of results within (and beyond) area of responsibility.
Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
Looks for opportunities for continuous improvement.
Company
Wise Equation Solutions Inc.
Wise Equation Solutions is one of the fastest growing Veteran – Owned enterprise in IT consulting and business services for small, mid and large organizations.
51-200 employees
H1B Sponsorship
Wise Equation Solutions Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (37)
2022 (34)
2021 (45)
2020 (53)
Funding
Current Stage
Growth StageCompany data provided by crunchbase
