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Regulatory Affairs Analyst Jobs in Suffolk, Massachusetts

Regulatory Affairs Consultant Jobs
By Connect Life Science At Boston, MA, United States
Solid experience of software and SaMD regulatory requirements for medical devices
Familiarity with software development life cycle methodologies, risk management, and QMS.
Provide guidance and support to cross-functional teams in the interpretation and implementation of software regulatory requirements, standards, and guidelines
Remote/Hybrid with site visits to Boston, MA
Medical Device & IVD Experience
Liaise directly with FDA to ensure successful 510K and product clearance
Head Of Regulatory Affairs
By Albion Rye Associates At Boston, MA, United States
Education, Qualifications, Skills & Experience:
Knowledge of Regulatory Affairs, working with products in early and late stages of clinical development
Experience working within Regulatory Affairs on a global level
Lead cross-functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
Lead a Global Regulatory Team
Deliver regulatory milestones on your team including an assessment of risks and mitigation, emerging data, and the probability of success.
Vp/Svp Regulatory Affairs
By GQR Global Markets At Boston, MA, United States
Demonstrated enterprise leader with a minimum of 5 years functional leadership and people management.
Experience leading, designing, writing, and submitting regulatory filings with BLA filing experience required. Previous product approval preferred.
Experience in neurology/rare disease and gene therapy areas preferred.
Excellent oral and written communications skills with the ability to compellingly influence.
Formulate a compelling strategy and drive the execution of tactical plans to achieve regulatory goals.
Oversee all regulatory submissions from pre-IND to BLA filings as well as all filing with health authorities on a global basis.
Regulatory Affairs Scientist Jobs
By Procter & Gamble At Boston, MA, United States
Independent regulatory manager, responsible for ensuring compliance of multiple product forms with North America.
Guides and influences project direction and solves significant technical problems by leveraging scientific skills.
Previous regulatory experience is favorable but not required.
Critically evaluates regulatory laws, develops regulatory strategies, identifies issues/risks and develop proactive plans to address.
Develop effective regulatory strategy for initiatives/projects by understanding the North America Regulatory framework impacting the Shave Care business.
Works x-functionally within R&D and Product Supply to incorporate regulatory compliance.
Senior Regulatory Affairs Officer
By Shorla Oncology At Massachusetts, United States

Shorla Oncology develops innovative solutions into effective oncology treatments to improve patients’ lives. The patients’ needs are at the heart of our innovation, ensuring we deliver affordable, ...

Senior Director Regulatory Affairs
By National Staffing Consultants (Discover Top Talent with Us!) At Cambridge, MA, United States
Experience working in a clinical biotech company is required.
NEW! Part time Consulting position 20+ hrs a month. Remote.
Preference is to be located on the east coast. HQ is in Cambridge.
Director/Senior Director Regulatory Affairs - Consultant
Regulatory & Clinical Affairs Specialist (Remote)
By Haemonetics At Middlesex County, MA, United States
Familiarity with medical device requirements in the US and/or EU (Class III experience is a plus)
Review QMS and product changes for compliance to regulatory requirements
Ensure compliance with corporate and regulatory requirements (e.g., GCP and ISO 14155).
Knowledge of medical device US and EU regulations, standards, and guidance documents (21 CFR 820, MDR, ISO 13585, ISO 14971, etc.)
2+ years previous experience in medical device product development or related field. Regulatory affairs, clinical affairs, or clinical research experience required.
Must be able to manage or support multiple projects.
California Regulatory Affairs Analyst (Hybrid)
By California ISO At Folsom, CA, United States
Level of Education and Discipline:
Participate in paid on-call rotation and other job-related duties as assigned.
May perform related duties and activities as assigned.
Adheres to and supports the Core Values of the ISO.
Quality And Regulatory Affairs Analyst - Genetics Clinical Trials
By Mount Sinai Health System At United States
Maintaining a working knowledge and thorough understanding of federal and institutional regulations and polices relating to human subjects research
2+ years of experience in clinical research
Experience using electronic regulatory platforms a plus
Experience with industry-sponsored clinical trials preferred
Conducting internal auditing and monitoring activities to ensure compliance with study protocols and applicable regulations
Assisting investigators and clinical research coordinators in preparing for site monitoring visits and audits
Regulatory Affairs Analyst Jobs
By San Jose Water At San Jose, CA, United States
Required Knowledge Skills & Abilities
· Working knowledge of statistics, investments, budgeting, project management and computerized applications.
· The Regulatory Affairs Analyst requires substantial technical skill in finance, economics, and statistics.
· Utility rate-making methodologies and legal requirements.
· Excellent written and oral communication skills.
· A bachelor's degree or equivalent in finance, economics, accounting, engineering or a closely related field.
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.
Regulatory Affairs Consultant - Usa Remote
By Alien Technology Transfer At ,
Provide training to company managers and other relevant team members in areas related to regulatory compliance and associated best practices;
Conduct thorough research and stay up-to-date with US regulatory requirements, guidelines, and industry best practices pertaining to healthcare products and pharmaceuticals.
Minimum of 5 years of experience as a Regulatory Affairs Consultant in the healthcare industry, with a focus on US regulations;
In-depth knowledge of US FDA regulations and guidelines for drug and medical device development and approval processes;
Exceptional research, analytical, and problem-solving skills;
Excellent written and verbal communication skills;
Regulatory Affairs Professional Jobs
By Sartorius At , Remote
Deep knowledge of the relevant Regulatory requirements
Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths
8+ years relevant experience within the Regulatory Affairs discipline
Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources.
Proven analytical skill and technical/scientific competence.
Strong initiation and organizational skills
Regulatory Analyst Jobs
By Workrise At Englewood, CO, United States
Ensures data quality, data management and reviews operations data for accuracy and makes corrections as necessary.
Bachelor’s degree in related field; will also consider work experience with position specific skills.
Requires advanced computer skills and knowledge of a variety of discipline specific software.
Knowledge of WellEZ, zdSCADA, Project Canary, CleanConnect AI, and Ecesis software.
3-5 years regulatory experience. (DJ Basin experience required)
Requires knowledge of petro-technical terms.
Regulatory Affairs Complaint Investigator (Fda)
By ZOLL LifeVest At , Pittsburgh, 15238
Experience with Microsoft Access Preferred
Strong knowledge of Microsoft Excel, Word, Outlook, and Adobe Acrobat software.
Location: Remote, PA, United States of America
Liaise with the distributor, service, and engineering departments in acquiring relevant information for complaint investigations.
Compile complaint investigation information for final RAE review and approval.
Provide administrative support during product recall notifications, advisory reports, and incident reports.
Regulatory Affairs - Chemistry Manufacturing Controls (Cmc)
By Keasis At United States
· Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers
· Knowledge ofregulatoryguidelines and relevant applications.
· Demonstrate effective leadership, communication, interpersonal skills, and soft skills.
Inviting applications for the role of CMC 3 Manager-RegulatoryAffairs !
Qualifications we seek in you!
• Proven and relevantregulatoryaffairs experience in pharmaceutical, vaccine, or biological products; or related fields
Regulatory Business Analyst Jobs
By Phyton Talent Advisors At New York, NY, United States
Create business requirement and functional specification documents.
Experience with various regulatory reporting types, including TRF/ORF, Equity Trading, Regulatory Option Trading, and Trace Reporting.
5+ years of experience in business analysis or data analysis.
Strong analytical and problem-solving abilities.
Excellent communication and interpersonal skills.
Knowledge of SQL, Python, or other programming languages is a plus.
Regulatory Affairs Leader Jobs
By GE HealthCare At Chicago, IL, United States
Professional experience in regulatory project management/program management and regulatory agency interactions.
Demonstrated life-long learner; eagerness to obtain new skills and knowledge.
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Proved work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics.
Professional experience in Regulatory Affairs / Quality Assurance.
Experience with Software as a Medical Device (SaMD), cybersecurity, and other non-device software products.
Regulatory Affairs Scientist – Nutritional Supplements
By Wellington Executive Search At Denver, CO, United States
Communicate to the Operations Manager, Director of Quality, or other Senior Management as appropriate any potential issue.
An experienced formulation and applications team
Prior experience working with documentation pertaining to nutritional supplements and ingredients
Good analytical problem-solving skills. Meticulous with follow-up
Good communication skills. Able to give clear directions to others.
Quality Assurance, Compliance, Labelling, Documentation, and Regulatory Requirements
Regulatory Affairs Consultant Jobs
By Life Science People At United States
Experience with prep and filing of the following applications: FDA IND/ANDA/NDA/BLA applications and maintenance submissions
Experience with leading cross-functional teams
As the roles can range, it would be ideal to have experience with the following:
5+ years in Regulatory Affairs (ex: generics, prescription drugs and biologics)
May require up to 10% travel
This would be a contract role, and they are open to either full-time or part-time capacity.
Regulatory Analyst Jobs
By Medix™ At Mississippi, United States
Two (2) years of clinical research regulatory, professional or related experience, one (1) year if bachelor’s degree.
2 Years of Regulatory Experience
CTEP / CTSU / NCI CIRB experience would be very helpful
Start up and ability to grow
The work will take you from the lab to the office to the board room.
Must demonstrate the ability to meet deadlines.
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.
Regulatory Affairs Sr/Mgr (Cmc)
By Biopeptek Pharmaceuticals LLC At Malvern, PA, United States
80% employer-paid MEDICAL HMO plan
80% employer-paid DENTAL PPO plan
We are in works to add 100% employer-paid Basic Life/AD&D + ST Disability
We will eventually also add a Medical PPO plan

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