Regulatory Affairs, Noram Jobs
By Biocon Biologics At New Jersey, United States
Minimum 12 years relevant experience out of which more than 5 years of people manager role
Responsible for Noram regulatory strategy of both products approved and products under development.
Will serve as the point of contact for the Agency’s interactions and act as local regulatory representative
Supports development of Noram regulatory policy priorities, generates policy positions, develops action plans.
Responsible to prepare, review and approval of module 1 sections in partnering with GRL and make them available for NDS submission
Assist North America head on product development strategy and participate in building the regulatory strategy.
Gas Regulatory Analyst Jobs
By PSEG At Newark, NJ, United States
In lieu of degree, 8 years experience in any of the same disciplines
Must possess initiative, strong analytical skills, attention to detail, strong interpersonal skills and ability to consistently meet deadlines
Must be results oriented and have good planning and organizational skills
Good working knowledge of Microsoft Office (Excel, Word, Powerpoint, Outlook)
Study both existing and potential new pipeline agreements to develop a strategy to maximize their value.
Analyze Ferc orders, rulemakings, and policy changes to assess the impact on the BGSS business.
Reviewer, Regulatory Affairs Advertising & Promotion
By Tris Pharma Inc At , Monmouth Junction, 08852, Nj
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Knowledge of pharmaceutical/biotechnology industry (i.e., Medical/Clinical Affairs, Regulatory Affairs, Commercial, Product Development, etc.) acquired through industry and/or academic experience
Minimum education and years of relevant work experience
Special knowledge or skills needed and/or licenses or certificates
Excellent verbal and written communication and skills
Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Program Assistant (Regulatory Affairs)
By Rutgers University At New Brunswick, NJ, United States
Equivalent education, experience, and/or training may be substituted for the degree.
Bachelor’s Degree plus one (1) year related experience.
Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel,Access, and PowerPoint.
Demonstrated effective oral and communication skills.
Bachelor’s Degree plus one (1) year related experience in a clinical research regulatory capacity.
Prepares and submits all necessary documents to the Institutional Review Board. Ensures regulatory approvals are obtained.
Analyst, Regulatory Supervision (Hybrid)
By Prudential Financial At Newark, NJ, United States
Identifies problems, informing and assisting management in the resolution of matter.
Strong organization skills with the ability to successfully multitask, manage change and receive detailed performance feedback
Frequently partner with external investment advisor contacts and partnerships with strategic relationship managers and risk groups.
Vet proposed transactions, considering internal guidelines as well as outside regulatory requirements to mitigate risk.
An Individual Contributor that demonstrates strong commitment to delivering a superior customer experience
Strong verbal and written communication skills with a solid understanding of conflict and problem resolution required
Specialist, Regulatory Affairs Jobs
By CHANEL At Piscataway, NJ, United States
Section 5: What skills you will learn? What experiences might you have?
Trained and acting in-person coverage for quality assurance (QA) personnel, as well as helping manage QA union inspectors when needed
Minimum Education: B.S. Chemistry or related science
Minimum Years of Experience: 1-3 years of Cosmetic or related industry experience
Special Requirements of the Position: French speaking a plus
Communication skills (both internal and external)
Regulatory Affairs Manager Jobs
By Talencio At Greater Minneapolis-St. Paul Area, United States
Provides leadership and supervision to the IRB & Regulatory Specialists, including coaching, performance management and staff development.
Cardiovascular research experience or general knowledge of common cardiovascular medical terminology
Experience developing and delivering educational content
Delivers routine educational and training content to research staff on an as-needed basis.
Other opportunities for significant, high-level contribution may be available dependent upon candidate interest and experience and program need.
5 years of experience in research with a deep understanding of the clinical research and IRB oversight processes
Director Of Regulatory Affairs
By Metric Search At Marlton, NJ, United States
Ensure that domestic and international regulatory filings assigned meet regulatory requirements.
Create project plan, manage timelines and priorities on all submissions
Manage technical file documentation for international approvals in multiple geographies.
Working knowledge of standards and regulations as outlined in the QMS documentation and structure.
Experience with Regulatory Affairs, with primary responsibility for preparing regulatory submissions for Class III devices
Electrophysiology or related life science experience
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

Are you looking for a challenging and rewarding career in Regulatory Affairs? We are looking for a Regulatory Affairs Analyst to join our team and help us ensure compliance with all applicable regulations. You will be responsible for researching and analyzing regulatory requirements, preparing regulatory submissions, and providing guidance to internal stakeholders. If you have a passion for regulatory compliance and are looking for an opportunity to make a difference, this could be the perfect job for you!

A Regulatory Affairs Analyst is responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They are responsible for researching, interpreting, and communicating regulatory requirements to internal stakeholders, as well as providing guidance on regulatory compliance.

What is Regulatory Affairs Analyst Job Skills Required?

• Knowledge of applicable laws and regulations
• Excellent research and analytical skills
• Strong communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to work under pressure and meet deadlines
• Proficiency in Microsoft Office Suite

What is Regulatory Affairs Analyst Job Qualifications?

• Bachelor’s degree in a related field such as law, public policy, or business
• Relevant experience in regulatory affairs
• Professional certification in regulatory affairs (e.g. Regulatory Affairs Professional Society (RAPS) certification)

What is Regulatory Affairs Analyst Job Knowledge?

• Knowledge of applicable laws and regulations
• Understanding of the regulatory environment and its impact on business operations
• Knowledge of the product development process
• Knowledge of the regulatory submission process

What is Regulatory Affairs Analyst Job Experience?

• Previous experience in regulatory affairs
• Experience in a related field such as law, public policy, or business

What is Regulatory Affairs Analyst Job Responsibilities?

• Research and interpret applicable laws and regulations
• Develop and maintain regulatory compliance strategies
• Prepare and submit regulatory documents
• Monitor regulatory changes and updates
• Provide guidance and advice on regulatory compliance
• Liaise with internal and external stakeholders
• Track and report on regulatory compliance activities