Register
Recruit Create CV

Regulatory Affairs Consultant Jobs

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;
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 Writing Consultant Jobs
By Skills Alliance At United States
Extensive experience in drafting MAA/BLA documentation.
6-10 years experience in regulatory affairs medical writing.
Be inspired by the collective expertise and shared commitment to transforming cancer treatment.
*𝐄𝐱𝐜𝐥𝐮𝐬𝐢𝐯𝐞 6 𝐌𝐨𝐧𝐭𝐡 𝐂𝐨𝐧𝐭𝐫𝐚𝐜𝐭 - 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐖𝐫𝐢𝐭𝐢𝐧𝐠 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐚𝐧𝐭 - 𝐑𝐞𝐦𝐨𝐭𝐞*
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.
Medical Affairs Consultant (Remote)
By Tandym Group At Princeton, NJ, United States
Coordinating with sales management to provide training to sales staff as needed
This position will work remotely.
Providing high quality scientific/clinical input and review of disease strategy plans, abstracts, posters, slides, manuscripts, educational materials, webcasts, etc.
10+ years’ experience in pharmaceutical industry
Pharmaceutical industry experience in Medical Affairs or Clinical Development Experience creating and managing budgets
Good knowledge of OPDP promotional regulations and pharmaceutical promotion standards
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
Regulatory Affairs Liaison Jobs
By EPM Scientific At United States
In-depth knowledge of relevant national and international regulatory requirements, guidelines, and standards, such as FDA, EMA, ISO, etc.
Proficient in using regulatory databases, document management systems, and other relevant software tools.
Familiarity with quality management systems (QMS) and regulatory compliance auditing is a plus.
Coordinate and manage regulatory submissions, including applications, registrations, notifications, and reports, ensuring completeness, accuracy, and adherence to specified timelines.
Conduct thorough research and analysis of regulatory requirements, guidelines, and industry best practices as needed – to ensure regulatory compliance.
Keep abreast of changes in regulatory requirements and communicate updates and potential impacts to relevant departments within the organization.
Regulatory Affairs Fda Consultant
By Arcondis Group At Texas, United States
Proficiency in project management and ability to handle multiple projects simultaneously.
In-depth knowledge of FDA regulations, guidelines, and submission processes for both medical devices and pharmaceutical products.
Excellent written and verbal communication skills.
Serve as the main liaison between clients and FDA, facilitating effective communication and swift resolution of issues.
Keep abreast of changes in FDA regulatory guidelines, standards, and policies, interpreting their implications for client projects.
Advise clients on the clinical data necessary to support device and drug approval, including the design and review of clinical studies.
Remote In Ma: Regulatory Cmc Consultant (233298)
By Black Diamond Networks At United States

Job Description: Our biotech client needs a Regulatory CMC Consultant. Job is Part-time. Some CAR-T experience is wanted for this. Some other projects are gene therapy which are on the backburner ...

Cmc Regulatory Affairs Consultant
By EPM Scientific At California, United States
Participate in the design, development and execution of regulatory strategies, regulatory risk management and contingency plans.
Proactively manage CMC aspects including overseeing preparation and submission of CMC submissions - including clinical trial applications.
Develop and assess CMC content to ensure it is complete, well-written, and meets all pertinent requirements.
10+ years’ experience in life sciences
5+ years’ relevant experience in regulatory affairs or related functions in drug or biologics development.
Experience as a regulatory contributor for global original IND, NDA, BLA MAA, filings in the US or Europe.
Sr Director Regulatory Affairs Cmc
By Discover International At United States
Extensive knowledge of global regulatory requirements and guidelines for CMC in drug development.
Provide strategic guidance on CMC requirements for drug development programs.
Strong leadership skills, with a track record of managing high-performing teams.
Excellent communication and interpersonal skills for effective collaboration.
Strong problem-solving and strategic thinking abilities.
Develop and implement global regulatory CMC strategies aligned with corporate objectives.
Regulatory Affairs Specialist Jobs
By Infobahn Softworld Inc At United States
Some project management experience is helpful.
6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
Remote Position, however, Wisconsin/Neenah local to work hybrid remote/on-site is extremely desired .
• Regulatory experiences on Class I Medical Device, Consumer Products and Cosmetic Products.
10. Support the regulatory intelligence monitoring program by assessing changes in regulation and determining impact to K-C medical device products.
: Job Title: Contingent Support Regulatory Affairs
Regulatory Affairs Specialist Jobs
By Real Staffing At Irvine, CA, United States
Support 510(k) reviews (if sufficient experience)
Excellent verbal and written communication skills
Experience in a collaborative cross-functional development environment
Experience with FDA’s ecopy submission template a plus
Assist with 510(k) IDE drafting/compilation
Assist with 510(k) ecopy and submission
Regulatory Affairs Coordinator Jobs
By Volt At Red Wing, MN, United States
Investigate, maintain, and manage regulatory product certification claims data, databases, documentation systems.
Ensure accurate data entries, database management.
Maintain clear, concise documentation, experienced in documentation control/coordination.
Review technical documents to retrieve information with high level accuracy.
Can read/understand technical documents such as product drawings, test reports, user instructions, product labels, specifications, standards, product claims etc.
As a Regulatory Coordinator you will
Regulatory Affairs Associate Jobs
By ABBVIE At , , Il
NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education
Liaises with vendors to communicate and coordinate legalization of documents in accordance with country requirements.
Receives projects from manager but has responsibility for managing own projects with oversights
Reviews project progress with manager on a regular basis and escalates issues
Required Education: Bachelor’s Degree in life sciences
Required Experience: 2 years pharmaceutical or industry related experience
Regulatory Affairs Specialist 2 Jobs
By Yale University At , New Haven, 06511, Ct
Preferred Education, Experience and Skills:
This position is working a remote schedule.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.); Internet skills.
Experience in clinical research in an academic setting preferred. Experience in a Cancer Center setting preferred.
SOCRA/ACRP/RAPs (or equivalent) certification preferred.
Comprehensive Cancer Center - Clinical Trials Operations
Regulatory Affairs Associate Jobs
By BioSpace At North Chicago, IL, United States
NOTE: Higher education may compensate for years of experience. Years of experience may also compensate for lower education
Liaises with vendors to communicate and coordinate legalization of documents in accordance with country requirements.
Receives projects from manager but has responsibility for managing own projects with oversights
Reviews project progress with manager on a regular basis and escalates issues
Required Education: Bachelor’s Degree in life sciences
Required Experience: 2 years pharmaceutical or industry related experience
Sr. Director Of Regulatory Affairs
By Simply Biotech At North Carolina, United States
10+ years of management experience in Regulatory with direct reports.
Responsible for the preparation and management of IND, BLA, 510(k) and/or other appropriate market authorization applications for existing and new products
Knowledge of FDA, Health Canada (HC) and United States Department of Agriculture (USDA) guidelines and requirements
5+ years of Pharmaceutical Industry Experience
Experience submitting to the FDA, HC, and USDA
Experience reviewing, revising, and authoring INDs, BLAs, and 510(k)s
Regulatory Affairs Associate Jobs
By Institutional Shareholder Services At , Rockville, 20850, Md
Bachelor’s degree with a strong academic record. Relevant internship or professional (e.g., public policy, economics, finance) experience.
We are proud to offer the following featured benefits
Excellent communication, both written and oral, and analytical skills.
FSA and Commuter benefit programs
Working with members of the ISS Regulatory Affairs team and internal stakeholders to identify policy risks and opportunities.
Tracking, synthesizing, and summarizing legislative and regulatory developments and proceedings, including for non-technical audiences.
Sr. Regulatory Affairs Specialist
By Abbott Laboratories At , Abbott Park, Il
Contribute to the development and functioning of the crisis/ issue management program
Determine and communicate submission and approval requirements
Participate in risk-benefit analysis for regulatory compliance
Assist compliance with product post marketing approval requirements
Submit and review change controls to determine the level of change and consequent submission requirements
Assist in SOP development and review

Are you looking for an exciting career in Regulatory Affairs? We are looking for an experienced Regulatory Affairs Consultant to join our team and help us ensure compliance with all applicable regulations. You will be responsible for providing strategic advice and guidance on regulatory matters, developing and implementing regulatory strategies, and managing the regulatory process. If you have a passion for regulatory affairs and are looking for a challenging and rewarding role, this could be the perfect opportunity for you!

Overview:

A Regulatory Affairs Consultant is a professional who provides advice and guidance to organizations on regulatory compliance. They are responsible for ensuring that the organization is compliant with all applicable laws and regulations, and that the organization is in compliance with the applicable industry standards.

Detailed Job Description:

A Regulatory Affairs Consultant is responsible for providing advice and guidance to organizations on regulatory compliance. They must be knowledgeable about the applicable laws and regulations, and must be able to interpret and apply them to the organization’s operations. They must also be able to provide guidance on the implementation of the applicable industry standards. They must be able to identify potential risks and develop strategies to mitigate them. They must also be able to provide guidance on the development of policies and procedures to ensure compliance with the applicable laws and regulations.

What is Regulatory Affairs Consultant Job Skills Required?

• Knowledge of applicable laws and regulations
• Knowledge of industry standards
• Ability to interpret and apply laws and regulations
• Ability to identify potential risks and develop strategies to mitigate them
• Ability to provide guidance on the development of policies and procedures
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to work under pressure

What is Regulatory Affairs Consultant Job Qualifications?

• Bachelor’s degree in a related field such as law, business, or public policy
• Previous experience in regulatory affairs or a related field
• Knowledge of applicable laws and regulations
• Knowledge of industry standards
• Excellent communication and interpersonal skills

What is Regulatory Affairs Consultant Job Knowledge?

• Knowledge of applicable laws and regulations
• Knowledge of industry standards
• Knowledge of risk management
• Knowledge of policy and procedure development
• Knowledge of compliance management

What is Regulatory Affairs Consultant Job Experience?

• Previous experience in regulatory affairs or a related field
• Experience in risk management
• Experience in policy and procedure development
• Experience in compliance management

What is Regulatory Affairs Consultant Job Responsibilities?

• Provide advice and guidance to organizations on regulatory compliance
• Interpret and apply applicable laws and regulations
• Identify potential risks and develop strategies to mitigate them
• Provide guidance on the development of policies and procedures
• Monitor and report on compliance with applicable laws and regulations
• Develop and implement training programs on regulatory compliance
• Develop and maintain relationships with regulatory authorities