Vice President Of Quality And Regulatory Affairs Jobs

At least 15 years of Global Regulatory Affairs leadership experience.

Extensive knowledge of ICH, FDA, EMA, HSA, PMDA, MFDS, and international regulations/guidelines.

Provide global regulatory leadership supporting global development.

Proactively participate in the design of US and ex-US regulatory strategies for the development of precision oncology therapies.

Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.

Form partnerships across the Science Units to provide/facilitate provisions of the appropriate regulatory affairs advice to each area.

Management review of quality and regulatory team.

Manage the preparation and development of regulatory submission packages.

Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.

Prior experience authoring and filing of regulatory documents.

Responsible for regulatory submission strategies to support product development and approval of various medical device products.

Interface with regulatory authorities and internal technical teams on regulatory submissions.

Offer strategic regulatory counsel to senior management.

Management of a large, global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities.

You must have at least 15 years of managerial experience in the medical devices sector.

Head a skilled, diverse regulatory affairs team adept at navigating global regulations.

Devise and execute strategies for prompt global product launch while adhering to regulations.

Assure comprehensive and lawful post-launch product backing.

Responsible for supporting the management of an operating budget for the department.

Maintains current knowledge of quality improvement information, patient safety, and regulatory requirements.

Coordinates all documentation requirements for the Performance Improvement and National Patient Safety Goal chapters of The Joint Commission manual.

Supports the coordination and direction all activities to ensure the effective implementation of the Quality Improvement Plan.

Designs, develops, implements and evaluates quality improvement policies and procedures.

Develops and facilitates the use of data collection tools to support data analysis.

Uses prior experience to ‘see around corners’ and anticipate changes needed to reflect growing complexity in strategy and business operations.

Experience working in global organizations and managing and building geographically dispersed teams preferred.

Partner with key stakeholders to ensure that quality strategy is aligned with business strategy to achieve company objectives

Maintain transparent reporting on KRIs and KPIs related to food safety and quality, sanitation, and internal and external audits.

Ensure regulatory compliance across all BYND activities.

Bachelor’s degree in Food Safety, Microbiology, Chemistry, Food Science, or other related field. Master’s degree highly preferred.

Manages and updates quality-related project manual policies and procedures and quality-related management software.

Provides ongoing status updates to executive management with recommendations for dealing with substandard performance and overall progress on quality goals.

Seeks out and leverage industry quality management program best practices to continuously improve the company program.

Develops and manages data analytics for the quality program by partnering with regions to effectively manage risk.

Must obtain a NACE Level 3 Coating Inspector (CIP) Certification - Required

10+ years of progressive experience related to quality control.

A minimum of at least 10 years of management experience (preferably all in sterile manufacturing)

Direct and manage all quality units at the site

Ensure site operations are in compliance with regulatory and corporate requirements

Site Quality Head experience in sterile manufacturing (5 years and above)

Drive cultural change through transformational and servant leadership

US or Canadian citizenship / relevant visa

Experience working in investments/asset management

Strong time management and organizational skills

10+ years’ experience in the investment management field including experience in investment portfolio compliance or other areas of compliance

Collaborate across firm functions, including trading, portfolio management, technology, product, and operations to design and implement efforts

Ensure the Global Investment Oversight Team is adequately trained on applicable regulation requirements and responsibilities for internal controls.

Attentiveness to stakeholder management, including success in building relationships across levels and functional groups

12+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing, or laboratory environment. 7-10 years experience in Quality Management.

Expert knowledge of GMP, FDA, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products

Regulatory Knowledge CBER, CDER, CDRH, and other global agencies

Experience interacting with FDA and other global agencies

Ability to prepare audit reports, quality agreements, standard operating procedures, and CAPA reports in accordance with companies Quality System requirements

Experience leading a Quality Dept at a CDMO (preferred)

Experience with faculty development and talent management, high-impact learning practices, online education, and competency-based education highly preferred.

Experience with management across multiple campuses preferred.

Demonstrated successful experience in strategic planning, fiscal management, resource allocation, hiring processes, and personnel supervision.

Knowledge of learning management software and principles of instructional design.

Demonstrated teaching and service experience as a full-time faculty member in higher education.

Ability to support and manage bachelor’s programs offered within the defined mission of Snow College.

Uses prior experience to ‘see around corners’ and anticipate changes needed to reflect growing complexity in strategy and business operations.

Experience working in global organizations and managing and building geographically dispersed teams preferred.

Partner with key stakeholders to ensure that quality strategy is aligned with business strategy to achieve company objectives

Maintain transparent reporting on KRIs and KPIs related to food safety and quality, sanitation, and internal and external audits.

Ensure regulatory compliance across all BYND activities.

Bachelor’s degree in Food Safety, Microbiology, Chemistry, Food Science, or other related field. Master’s degree highly preferred.

10+ years relevant experience in government affairs, including strategic leadership and managerial responsibilities.

Required Skills, Knowledge, and Abilities

Collaborate with external affairs colleagues across the country to stay informed of best practices and trends in higher education

A deep understanding of New York City and State government structures and processes, with federal knowledge and global fluency a plus

Experience as a problem solver who can mediate resolutions between differing interests, both internally and externally

Ability to think strategically, build consensus, influence decisions, manage change, articulate priorities, and execute plans for government affairs and community engagement

Maintain up-to-date knowledge of regulatory requirements and provide medical input for successful product submissions.

Identify, engage and manage relationships with thought leaders, key opinion leaders, and investigators.

At least 10 years of experience in the medical device industry.

Strong communication, organizational and leadership skills.

Ability to manage multiple projects and priorities in a fast-paced environment.

Plan and implement medical affairs strategies that support the development and commercialization.

Collaborate with internal business partners in development, asset management, legal, transmission, interconnection and origination functions

Preferably a BS in Business, Economics, Finance, or Engineering or commensurate job experience. MBA or law degree preferred.

Collaborate with the other Regulatory Affairs team members in other regions and manage direct reports as appropriate

Manage external counsel and consultants

Knowledge of organized power markets. Knowledge of CAISO and ERCOT highly preferred.

Knowledge of FERC and NERC standards related to transmission and interconnections, including Open Access Transmission Tariff (OATT) preferred.

In-depth knowledge of global regulatory requirements

Establish and maintain relationships with senior regulatory consultants and advisors; manages regulatory vendors and budget

Ensure compliance with applicable regulatory reporting requirements, laws and regulations

Science degree (PhD, PharmD, MD, MSc) with extensive experience in regulatory leadership

Minimum of 10 years of experience in Regulatory Affairs in the biopharmaceutical industry

Prior experience in dermatology or immunology and inflammation preferred

Excellent project management, time management, and planning skills.

Assists in supporting Quality initiatives for owned, managed, leased, and consulting facilities.

Supports Regulatory Compliance and provides regulatory support for owned, managed and leased facilities.

Supports and leads Productivity initiatives for owned, managed and leased facilities.

Proficient knowledge of regulatory agency standards and the ability to assist hospitals in meeting standards and prepare for surveys and inspections.

Develops and manages a directory of documents that supports clinical, regulatory and quality initiatives for the owned, managed and leased facilities.

5+ years’ medical device Regulatory Affairs experience with ophthalmic devices.

Proven success in a Regulatory leadership position (Senior Manager’s & Manager’s will be considered)

Experience working internationally and available to travel

Proven track record with PMA, 510(k), EUMDR, FDA.

Educated to Bachelor’s degree level in a related discipline.

Be instrumental in launching a disruptive device that will create a new gold standard in patient care

Ensure the qualification, selection and management of vendors and contractors through a defined qualified process

Design and maintain a fit-for-purpose quality management system (QMS) across the GxPs

Develop and manage Global Regulatory Affairs and QA budgets

Extensive experience leading, designing, writing and submission of regulatory filings and correspondence

Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on project activities

Strong problem solving, critical thinking and analytical skills, required to make sound decisions

• Possesses strong leadership, management, advocacy, and organizational skills.

Minimum Education and Experience Required

AHIP is looking for an experienced Vice President, Federal Affairs to join their team!

1. Bachelor's Degree in Political Science or related field and/or equivalent experience.

• Knowledge of PAC organization and rules.

• Excellent oral and written communication skills• Ability to build collaborative relationships