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Specialist Operations Regulatory Compliance Jobs

Regulatory Operations Specialist Jobs
By CymaBay Therapeutics At Newark, CA, United States
Proficient in Microsoft Word, EndNote, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel, StartingPoint templates
Manage the regulatory activities log tracking annual and current submissions
Direct publishing experience a plus
Knowledge of the regulatory archival, records and submissions systems with demonstrated ability to learn new systems and processes.
Experience in preparing INDs, CTAs, NDAs, BLAs and MAAs
Excellent writing skills (e.g., English usage), a keen attention to detail, and strong verbal and interpersonal communication skills
Remote Regulatory Compliance Specialist
By Comrise At Allendale, NJ, United States
Regulatory Compliance Specialist-REMOTE 6-12 months contract
1. Updating and maintaining product field action records in Trackwise electronic database (Trackwise experience preferred)
Medical Device or Pharmaceutical Industry experience preferred.
Assist with general Product Field Action execution activities, including but not limited to:
2. Contacting domestic hospital customers to confirm receipt of field action notifications, and documenting and tracking responses
3. Communicating with domestic and international Company affiliates to support execution of field actions in local markets
Manager, Regulatory Compliance And Operations
By bluebird bio At United States
Preparation and management of procedural documents
Experience working or interacting in a hybrid or fully-remote work environment
Experience with the Microsoft suite of software, e.g., Word, Excel, SharePoint, Project, PowerPoint, Visio
Experience organizing information or managing large projects
Strong verbal and written skills
Responses to requests for regulatory documentation
Regulatory Operations Specialist Jobs
By LeadStack Inc. At United States
May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.
Arranges event planning for internal meetings and Kaizen events, including ordering supplies, coordinating meals, arranging hotel room blocks, etc.
Maintains organizational charts for both departments and maintain email distribution lists.
Supports expense reporting for leadership in GRA and GCA.
Title: Global Clinical & Regulatory Affairs Operations Coordinator
8:00 AM - 5:00 PM EST (includes one hour lunch)
Regulatory Compliance Specialist Jobs
By Synergis At Mountain View, CA, United States
2+ years working in a fast-paced environment that required laser-like attention to detail and organization skills
1+ year of experience assembling and/or tracking critical documentation
Excellent people skills and a can-do attitude
Experience with Adobe Acrobat and/or Illustrator
Regulatory Compliance Associate Required Experience:
Regulatory Compliance Associate Preferred Experience:
Regulatory Compliance Specialist Jobs
By Lumen Solutions Group Inc. At Baltimore, MD, United States
Enrollment, claims, utilization management, credentialing
Works in conducting compliance incident management.
Ranging from review and analysis of policies and procedures
Development policies and procedures for Medicaid and Medicare
Monitoring enrollment in Medicare and Medicaid
Reviewing communication from Federal and State
Regulatory Compliance Specialist (Healthcare)
By Bernard Nickels & Associates At United States
Work Location: Remote (United States)
• Bachelor’s Degree or equivalent work experience
• Analytical experience and advanced proficiency with translating analysis to written & oral communications.
• Strong organizational and prioritization skills, and ability to balance multiple tasks.
• 8+ years of experience in healthcare regulatory compliance.
• Extensive knowledge of healthcare industry regulations and governing laws.
Manager, Regulatory Operations - Remote
By Oscar Health At United States
Project management and process improvement experience
Proficiency in designing and improving workflows, and demonstrative project management experience.
5+ years of healthcare industry regulatory analysis experience, in the health plan/managed care space.
Project manage the internal tracking and monitoring of Regulatory Operations team deliverables related to our Legislative processes.
A bachelor's degree in a legal, healthcare-related or humanities field, or 4 years commensurate experience.
Be the EOC SME for the regulatory operations ecosystem and current strengths, weaknesses, and gaps within important region(s)
Lead Specialist - Compliance & Regulatory (Remote Us)
By GE Aerospace At Evendale, OH, United States
A minimum of 4 years of professional experience in Ombuds, workplace investigations, compliance, law, internal audit, controllership, or related field.
Outstanding communication and interpersonal skills with the ability to work effectively with people at various levels of the organization .
Proven analytical and evaluation skills .
Process and detail-oriented, including strong organizational skills and ability to prioritize .
Strong oral and written communication skills .
Strong skillset in Power Point and Excel .
Quality & Regulatory Compliance Specialist Salty Snacks
By The Hershey Company At Hershey, PA, United States
Minimum knowledge, skills and abilities required to successfully perform major duties/responsibilities:
Minimum Education and Experience Requirements:
Detailed knowledge of regulatory and quality system requirements – Hershey’s Product Excellence Program, Food Safety (FSMA, HACCP), Good Manufacturing Process (GMP).
Scope of interaction: Managers, Directors, Manufacturing Plants, Corporate and External Suppliers and Customers.
Coordination of activities: Managers, Directors, Corporate and External Contacts
Knowledge of federal and state food industry regulations including Food Safety Modernization Act
People Operations Specialist, Compliance
By Block At New York, NY, United States
HR operational experience in several HR areas (e.g., Benefits, Compensation, Immigration)
Work with our internal legal team to validate compliance requirements
Experience implementing processes that scale
Broad experience with software tools and systems
Experience in HR Compliance or a People Operations role that included compliance
Experience managing the Form I-9 process
Regulatory Compliance Specialist Jobs
By PharmaCann Inc At Chicago, IL, United States
Management Plans and Security Plans as needed.
● Strong analytical skills, including demonstrated experience identifying and quantifying
● Detail oriented, excellent judgment and time management with ability to manage multiple
Company operates. The Regulatory Compliance Associate will manage and maintain
levels within the Company. The ideal candidate will possess outstanding organizational skills,
strong attention to detail, and a proven ability to effectively manage multiple priorities in an
Regulatory Compliance Specialist Jobs
By BCforward At New York, NY, United States
• Bachelor's degree required or equivalent experience ( - law degree/qualification would be an advantage)
• Support the definition of control requirements and control standards appropriate for the relevant regulations:
• 5+ years minimum relevant experience
• Prior experience in regulatory driven remediation e.g., MRA, Consent Order etc. and advantage
Title : Regulatory Compliance Lead
o 12 USC 24 (Seventh);
Senior Regulatory Compliance Specialist
By Empower At United States
Compile statistical data and narrative trend analysis reports as required by regulators and/or for internal management.
Update organizational compliance policies, as well as internal department policies and procedures for review/approval by management.
Facilitate implementation of various SEC, FINRA and/or State regulatory requirement(s) and development of effective and efficient compliance supervisory oversight programs.
Bachelor's degree or equivalent work experience.
5+ years financial services experience, with minimum 2 years in directly related securities compliance role.
Respond to a broad range of questions from internal business personnel regarding compliance matters.
Healthcare Regulatory & Compliance Specialist
By Suvida Healthcare At Houston, TX, United States
C. General legal matters and overall risk management, including privacy and security, patient complaints and any filings and/or applicable responses.
· Self-starter and interested in learning and developing expertise in new and emerging areas through education, networking and new experiences
And state and federal regulatory requirements.
· Research and communicate legal and regulatory requirements
· Provide ongoing compliance education and training to employees
· Certification in Compliance, Masters or JD in Law or bachelor’s degree in Business Administration or Healthcare Administration preferred
Regulatory Affairs Specialist, Copy Compliance
By BeneFit Cosmetics At , San Francisco, 94104, Ca $62,000 - $83,000 a year
Manage review of website product copy, PR copy, visual merchandising assets, videos, FAQ and toolkit copy for global compliance.
4 to 5 years’ experience in cosmetic regulatory affairs, specifically in identifying risk level of global cosmetic or OTC claims
Experience working with industry counterparts and trade associations
Clear verbal, reasoning, and written communication skills.
Skills at summarizing complex regulations in simple terms.
Strong partnership skills to analyse and problem-solve in team dynamic.
Senior Regulatory Compliance Specialist
By Alani Nutrition At Louisville, KY, United States
Ensure advanced knowledge and understanding of relevant regulatory trends in nutrition, labeling, foods, and food standards.
Education: Bachelor’s degree in Food Science, Chemistry, Biology, or related fields.
Experience: Minimum 6 years of responsibility in food/beverage or supplement industry.
Knowledge of regulatory affairs, quality documentation, and business processes (stage gates).
Excellent communication skills, both written and oral.
Experience with ESHA Genesis is preferred but not required.
Regulatory Compliance Specialist Jobs
By iLocatum At Irvine, CA, United States
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Develops risk assessment review process for all marketed devices and implementation of changes to risk management process as needed.
Collaborates and takes direction from RA management.
Provides guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions.
Strong working knowledge of US and EU regulations that affect Class III medical devices.
Experience working on cross functional projects.
Regulatory Operations Specialist Jobs
By Jobot At San Diego, CA, United States
Incredible company culture and proven management team
MS WORD knowledge with WORD styles to format various documents for regulatory submissions
ECTD publishing experience with using eCTD software to produce a compliant electronic submission
3+ years of Regulatory Proofreading/Publishing experience within biopharma, medical device, IVD, or CRO industries (protocols, amendments, IBs, CSRs, INDs, NDA modules)
QC experience is a plus
REMOTE | Regulatory Publishing/QC opportunity with a well-funded Rare Disease biotech
Nepa Senior Regulatory Compliance Specialist
By Sealaska Remediation Solutions, LLC At United States

Job Summary: The Senior Regulatory Document Specialist will support environmental projects. Position will apply regulatory analysis for technical projects for National Environmental Policy Act ...