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Regulatory Affairs Jobs in Suffolk, Massachusetts

Regulatory Affairs Manager Jobs
By Korn Ferry At Boston, MA, United States
5+ years of experience in regulatory affairs environment in nutrition industry.
Excellent knowledge of US and Canada Food Law - Regulations.
Korn Ferry has partnered with our client on their search for the role, Regulatory Affairs Manager.
Ensure compliance of product, ingredients, and claims.
Supply regulatory support for safety files and clinical trials/protocols in order to support R&D.
Vetting and approval of all public materials, including labelling.
Regulatory Affairs Cmc Specialist (Remote)
By Navitas Life Sciences At Boston, MA, United States
8 to 12 years’ experience working in a regulated, life science environment with Strong project management interpersonal skills.
Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, Resource Forecasting.
Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines.
Responsible for Product lifecycle management & plan for global regulatory filings and assessments as required by the individual project.
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements.
Should have demonstrated ability to manage the product life cycle submissions in key regulated markets like US, Canada, UK & EU.
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
Senior Regulatory Affairs Specialist
By Navitas Life Sciences At Boston, MA, United States
8 to 12 years’ experience working in a regulated, life science environment with Strong project management interpersonal skills.
Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, Resource Forecasting.
Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines.
Responsible for Product lifecycle management & plan for global regulatory filings and assessments as required by the individual project.
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements.
Should have demonstrated ability to manage the product life cycle submissions in key regulated markets like US, Canada, UK & EU.
Director Of Regulatory Affairs
By Hemab Therapeutics At Boston, MA, United States
Direct point of contact with health authorities, leads and manages Regulatory Agency meetings, in cooperation with outsourced vendors.
Bachelors degree in a scientific subject area coupled with sufficient industry experience. Advanced degree (e.g. MSc, PhD, PharmD, MD) preferred.
Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
Participates with influence in or leads departmental and cross-functional taskforces and initiatives.
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.
Regulatory Affairs Lead Jobs
By Bramwith Consulting At Massachusetts, United States
Ensure sustained quality and efficiency through modern artwork management systems
Extensive experience working with Healthcare/Pharmaceutical product labelling
Consistently drive continuous improvement related to global Pharmaceutical labelling
Work highly cross-functionally with wider global teams, and educate global stakeholders of labelling best practices
Strong understanding of Pharmaceutical Regulatory Bodies across a global remit
Degree from a leading college
Director Or Sr Director Regulatory Affairs - East Coast Remote Flex
By GQR Global Markets At Massachusetts, United States
Manage third party vendor partner performance and workload to support regulatory operations and regulatory publishing.
Manage regulatory budgets, resources, and timelines to optimize operational efficiency and meet business objectives.
Experience in managing regulatory inspections, audits, and interactions with regulatory agencies including direct contact with regulatory agencies.
Final accountability for regulatory documentation, ensuring adherence to FDA and other health authority specifications and timelines
Preference for East Coast-based candidates.
Regulatory Affairs Associate Jobs
By Mindlance At Plymouth, MN, United States
Skills: Knowledge of US and/or Canadian regulation relating to product and/or device clearance
Communicates issues to management through project management tracking and issue briefings.
Minimum of 3 years’ experience
Ability to manage and track broad and strategic projects.
Responsible for effective communication of regulatory requirements to project teams and internal customers.
Position is highly visible to internal and external stakeholders.
Senior Director, Regulatory Affairs
By Relay Therapeutics At Cambridge, MA, United States

You have earned your B.S and/or M.S. and bring 10+ years of relevant work experience in pharmaceutical regulatory affairs.

You have a "can do" attitude, and you are passionate about the impact of regulatory work on patients.

Director, Global Regulatory Affairs
By NextPoint Therapeutics, Inc. At Cambridge, MA, United States
Experience managing annual reports, IND amendments, IB updates, DSURs for lifecycle management of our pipeline programs.
Lead and manage all interactions/meetings with FDA and other health authorities.
Lead and manage preparation and submission of all regulatory documents across clinical and pre-clinical programs, including authoring where necessary.
Experience with oncology drug development required, experience in immuno-oncology drug development strongly preferred.
Experience with filing INDs required. Experience with direct interactions with FDA required.
Experience with biomarker strategies preferred, experience with companion diagnostic development a plus.
Regulatory Affairs Specialist Jobs
By Intellectt Inc At Plymouth, MN, United States
Have working knowledge in EU MDR
Have working knowledge in Regulatory Change Assessments
Have working knowledge in US and EU medical device submissions
Have experience supporting internal and external inspections
Have experience with continuous improvement activities
BA Degree Required and 2-4 years of experiences in Medical Device Regulatory Affairs
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.
Senior Specialist, Regulatory Affairs
By H&H Group At Orlando, FL, United States
Good communication skills, strong project management ability and teamwork ability.
Familiar with the process of pet food export to China, experience in official certification documents works.
Salary and benefits will be competitive and commensurate with experience.
At least 1 year working experience in pet food
MOA registration program U.S. official documentation section
Label and advertising compliance review
Director Of Regulatory Affairs
By Trebla Talent At Greater Chicago Area, United States
Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; NDA experience is required.
Minimum of 10 years of experience across Regulatory Affairs or another transferrable function in biotech/pharma
Both clinical and CMC experience is desired
Bachelor’s degree is required; advanced degree is preferred.
A passion for the psychedelic and mental health industry
Director/Senior Director of Regulatory Affairs
Director Regulatory Affairs Jobs
By Altasciences At United States
Critical thinking skills and ability to acquire and apply knowledge quickly;
Lead, manage and prepare clinical trial submissions;
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
8+ years of regulatory experience in an industry setting;
Strong knowledge of drug development and regulatory policy;
Remote: Vice President Regulatory Affairs
By Shepherd Regulatory Search At United States
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.
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.
Regulatory Affairs Associate Jobs
By Agilent Technologies At California, United States
Compile materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
Maintain and updates information about global regulatory requirements.
4+ years of Regulatory Affairs experience
Post-graduate and/or certification/ license may be required.
Review product labeling and marketing materials for accuracy and compliance with regulations.
Respond to customers and/or authorities requests/inquiries dealing with regulations and product compliance.
Regulatory Affairs Consultant (Freelance)
By Alien Technology Transfer At United States
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;
Assistant Director Of Regulatory Affairs
By NC Real Estate Commission At West Bend, NC, United States

Attorney needed to assist division director with supervisory and managerial responsibilities and to prosecute cases involving allegations of violations of Real Estate License Law and Commission ...

International Regulatory Affairs Specialist
By Scholl's Wellness Company At Parsippany, NJ, United States

Seeking a part time International regulatory consultant to help manage International product registrations in select International markets Must be familiar with the International registration process ...

Regulatory Affairs Manager Jobs
By Jobot At New York, NY, United States
Strong knowledge of OTC drug and device regulations, including labeling requirements
Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
Working knowledge of U.S. clinical research and claims support
Excellent written and verbal communication skills
6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
Drug or medical device submission and/or maintenance experience
Program Manager (Quality & Regulatory Affairs) - Remote
By Olympus Corporation of the Americas At United States
Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.
Many years in complex projects or programs including first experience in portfolio management.
Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.
Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.
Experienced in strategic planning and risk management.
MS Project and project management tools.
Regulatory Affairs Specialist Jobs
By Managed Staffing, Inc. At Austin, TX, United States
6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
The job description is detailed below:
Duration: 1+ year with possibility of extension
5. Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances