Regulatory Affairs Strategist Jobs
By Navitas Life Sciences At , Remote
Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines
Support delivery in performing project management activities or as an individual contributor for a deliverable, managing relationships with all stakeholders
Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
There is a travel requirement of up to 10%
Knowledge of IND/NDA/BLA submissions and life cycle submissions for the US market
Strategist Jobs
By Blue Cross Blue Shield of Michigan At Detroit, MI, United States
Provide solutions to complex business problems and make recommendations to senior management to improve strategic initiatives and technical processes.
Ability to effective interface with management at all levels and external contacts.
Manage activities that are directly related to the corporate strategies, goals and objectives.
Five (5) years of experience in corporate strategy, consulting, investment banking or related experience is required.
Previous experience leading projects and/or teams is preferred.
Previous experience working in the healthcare industry is preferred.
Investment Strategist Jobs
By KLR Wealth Management, LLC At Rhode Island, United States
KLR and KLR Wealth Management offers a comprehensive compensation and benefits package, including:
Maintains a high-level relationship with all investment management partners
Experience managing multi asset model portfolios, including mutual funds, ETF’s, and separately managed accounts
Actively manages the firm’s model strategies
Leads the ongoing due diligence effort on existing and new investment managers
Attends industry due diligence and networking events to enhance product and industry knowledge
Senior Regulatory Strategist Jobs
By Veristat At United States
Benefits vary by location and may include:
In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies.
Demonstrated ability to lead by example and demonstrated skill for technical leadership of staff.
Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.
Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.
Driving/Travel requirements–0-20% (US, Canada, International)
Investment Strategist Jobs
By Rockefeller Capital Management At New York, NY, United States
3 to 5 years of experience in investment management
Knowledge of essential statistical concepts and techniques for finance (e.g., regression)
Educational background in economics, finance, mathematics, and statistics preferred
Ability to prioritize responsibilities, conduct cost benefit analyses of increased complexity, and
Develop presentations that reflect qualitative and quantitative findings of an investment manager
Robust knowledge of and a curiosity for macroeconomics, financial markets, risk premium concepts,
Director Regulatory Strategist Jobs
By Viatris At United States
Extensive knowledge of the regulatory environment and ability to leverage this to impact regulatory strategy development and implementation
Knowledge of assigned therapeutic areas/disease areas is preferred
Regulatory Affairs Professional Certification preferred
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Regulatory Advisor Jobs
By Omnitrans At New York City Metropolitan Area, United States
Must have strong classification and appraisement skills, having 2 or more years’ experience in this area.
Completion of University degree or equivalent experience.
Ability to multitask; very organized, high degree of communication and analytical skills.
Candidate must have excellent writing skills.
5+ years of comparable Customs Operations experience.
Excellent working knowledge of Title 19 of the Code of Federal Regulations and United States Code.
Inspector - Regulatory Jobs
By Maricopa County At Phoenix, AZ, United States
A combination of post-secondary education and/or job-related experience may substitute for the minimum qualifications on a year-for-year basis
MSHA Mine Safety Class and Certification or ability to obtain certification within two months
Perform work with a greater purpose
Opportunities for growth and development within Maricopa County
Exceptional work-life balance, with hybrid and alternative work schedule options
Low-cost, high-value healthcare for you and your qualifying dependents
Regulatory Cmc Jobs
By Discover International At United States
Strong project management skills, with the ability to manage multiple projects simultaneously.
Develop and implement CMC regulatory strategies for new product development and product lifecycle management.
Knowledge of regulatory requirements and guidelines, including FDA and EMA regulations
Manage and oversee the preparation and submission of regulatory documents, including INDs, BLAs, and amendments.
Provide guidance and support to cross-functional teams on regulatory CMC requirements and strategies.
Stay up to date with changes in regulatory requirements and industry trends that may impact product development and regulatory submissions.
Regulatory Intern Jobs
By Tarte Cosmetics At New York, NY, United States
Manage Regulatory Information for New Product Development (NPD)
Support retail teams for registration in international markets
Execute and assist in registration process by submitting formulations for third-party review
Review documentation for accuracy and compliance with US and international markets
Highly motivated with the ability to thrive and multi-task in a fast-paced and demanding environment, passionate about cosmetics.
Request and submit samples for testing
Regulatory Paralegal Jobs
By Estrin Legal Staffing At Washington DC-Baltimore Area, United States
Experience with FTC advertising requirements, claims substantiation, investigations, and regulations.
Knowledge of 510(k) assessments, recall issues, import/export matters, and FDA inspections.
Must have at least one year of Paralegal experience
Preferred qualifications for this Paralegal role include:
What you bring to the table as an experienced Paralegal:
At least one year of Paralegal experience is required.
Iso Regulatory Jobs
By Mizuho At New York, NY, United States
Strong project management and organizational skills
Engage in personal and professional development projects to maintain continual growth in professional skills and knowledge essential for regulatory requirements
Demonstrates highly effective communications skills with the ability to influence business units
Ability to independently work, be counted upon, manage priorities, and remain flexible in a changing environment while meeting project timelines
Excellent interpersonal skills along with strong written and verbal communication skills across all levels of the organization
5+ years’ cybersecurity experience with at least 3+ years in an operationally focused security practitioner role
Regulatory Designer - Actalent
By Actalent At Holtsville, NY, United States
Preferred Education: Associates degree in graphic design or related field, or equivalent experience
Effectively manages projects of moderate scope including planning, control, and delivery against timeline and budget metrics
Documents progress against the project plan throughout the project. Formulates status reports and presents to the team and immediate manager.
Preferred Work Experience (years): 1-2 years of experience
Possess strong written and oral communication skills
Intermediate presentation skills to cross functional audience.
Global Regulatory Lead & Head Of Regulatory Labeling
By Karyopharm Therapeutics Inc. At , Remote $175,000 - $300,000 a year
Knowledge of global regulatory requirements
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Responsible for regulatory compliance with pre- and post-approval filings and reporting requirements
Minimum 10+ years’ regulatory strategy background with experience in the MDS, AML, or MM space
Preferences include recent successful NDA experience, as well as experience within a matrix environment
Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
Regulatory Strategist, Global Regulatory Affairs
By Kite Pharma At Santa Monica, CA, United States
Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.
Knowledgeable with the drug development process, cell therapy industry, and Regulatory practices; eCTD submission experience highly preferred
Helps expedite and improve regulatory administrative activities by training and advising new or less experienced colleagues.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
Master’s and 2+ years of relevant experience OR
Bachelor’s and 4+ years of relevant experience OR
Regulatory Consultant - Dr Phillips Hospital
By Orlando Health At , Orlando, 32806, Fl
Educates organization leadership and medical staff on changes to accreditation /regulatory requirements.
Provides regulatory guidance and support to medical staff and operations leaders /councils pursuing specific TJC certifications.
Actively performs audits to evaluate compliance on regulatory requirements. Directs development and implementation of action plans to address non-compliance.
Mentors and provides guidance for the development of educational opportunities for the organization relative to standards and accreditation regulations.
Five (5) years of clinical or related experience, including experience in healthcare quality/performance improvement projects
Responsible for completion of components of The Joint Commission application for submission of required data and documentation.
Regulatory Strategist, Global Regulatory Affairs
By Kite Pharma At , Santa Monica, Ca $94,690 - $122,540 a year
Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.
Knowledgeable with the drug development process, cell therapy industry, and Regulatory practices; eCTD submission experience highly preferred
Helps expedite and improve regulatory administrative activities by training and advising new or less experienced colleagues.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
Master’s and 2+ years of relevant experience OR
Bachelor’s and 4+ years of relevant experience OR
Regulatory Advisor Jobs
By Planet Pharma At Greater Chicago Area, United States
Training/Experience Requirements:At least 10 years drug OR device regulatory experience.
Responsibilities include:Develop regulatory strategies for global submissions
Manage FDA and other global health authority face-face communications and via all other communication channels
Some experience in quality assurance roles or auditing preferred
Both drug and device experience a plus
Mix of large sponsor company and small startup experience a plus
Regulatory Affairs Strategist (Remote Position)
By Navitas Life Sciences At Princeton, NJ, United States
Minimum Required Education and Experience:
oncology, Process and Change Management, KPIs and Metrics, Project Management
Location – US (Remote opportunity)
Responsibilities Includes but not limited to:
10 to 15 years’ experience
Strong Experience in Regulatory strategy in particular with
Vp| Regulatory Implementation Legal
By Barclays At , New York, 10019, Ny $250,750 - $310,250 a year
Over five years of experience at a nationally recognized law firm and/or in-house at a financial institution
Excellent written and oral communication skills
Skilled to communicate organizational values, address conflicts and deliver difficult messages
Skills that will help you in the role:
Working with stakeholders across the group to develop integrated global regulatory strategies
Monitoring legal and regulatory developments in multiple jurisdictions and anticipating and assessing impact on Barclays’ core businesses

Are you looking for an exciting opportunity to shape the future of regulation? We are looking for a Regulatory Strategist to join our team and help us develop innovative solutions to complex regulatory challenges. As a Regulatory Strategist, you will be responsible for researching and analyzing regulatory trends, developing strategies to ensure compliance, and providing guidance to our team on regulatory matters. If you are an analytical thinker with a passion for regulatory compliance, this is the perfect job for you!

Overview:

A Regulatory Strategist is a professional who is responsible for developing and implementing strategies to ensure compliance with applicable laws and regulations. They are responsible for researching and analyzing regulatory requirements, developing strategies to ensure compliance, and providing advice and guidance to stakeholders.

Detailed Job Description:

A Regulatory Strategist is responsible for developing and implementing strategies to ensure compliance with applicable laws and regulations. They are responsible for researching and analyzing regulatory requirements, developing strategies to ensure compliance, and providing advice and guidance to stakeholders. They must have an in-depth understanding of the regulatory environment and be able to interpret and apply regulations to specific situations. They must also be able to identify potential risks and develop strategies to mitigate them.

What is Regulatory Strategist Job Skills Required?

• Knowledge of applicable laws and regulations
• Ability to interpret and apply regulations to specific situations
• Ability to identify potential risks and develop strategies to mitigate them
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong analytical and problem-solving skills
• Ability to work under pressure and meet deadlines

What is Regulatory Strategist Job Qualifications?

• Bachelor’s degree in law, business, or a related field
• At least 5 years of experience in a regulatory or compliance role
• Knowledge of applicable laws and regulations
• Ability to interpret and apply regulations to specific situations
• Excellent communication and interpersonal skills

What is Regulatory Strategist Job Knowledge?

• Knowledge of applicable laws and regulations
• Ability to interpret and apply regulations to specific situations
• Knowledge of risk management principles
• Knowledge of industry best practices
• Knowledge of data privacy and security regulations

What is Regulatory Strategist Job Experience?

• At least 5 years of experience in a regulatory or compliance role
• Experience in developing and implementing strategies to ensure compliance with applicable laws and regulations
• Experience in researching and analyzing regulatory requirements
• Experience in providing advice and guidance to stakeholders

What is Regulatory Strategist Job Responsibilities?

• Research and analyze applicable laws and regulations
• Develop strategies to ensure compliance with applicable laws and regulations
• Provide advice and guidance to stakeholders
• Identify potential risks and develop strategies to mitigate them
• Monitor changes in the regulatory environment and update strategies accordingly
• Prepare reports and presentations to communicate findings and recommendations