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Regulatory Affairs Scientist Jobs

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 ...

Vice President Regulatory Affairs
By Albion Rye Associates At United States
Offer strategic regulatory counsel to senior management.
Management of a large, global product portfolio with a demonstrated ability to manage a wide array of simultaneous activities.
You must have at least 15 years of managerial experience in the medical devices sector.
Head a skilled, diverse regulatory affairs team adept at navigating global regulations.
Devise and execute strategies for prompt global product launch while adhering to regulations.
Assure comprehensive and lawful post-launch product backing.
Regulatory Affairs Lead Jobs
By Bramwith Consulting At United States
Bachelors degree in a scientific discipline or relevant experience (post-graduate degree is preferred but not a requirement)
Experience working within US regulatory affairs within the pharmaceutical or healthcare industry
Experience of regulatory submissions and approvals, including new BLAs/NDAs
Experience with licensing including negotiating directly with the FDA
Salary - $150,000 to $160,000 plus excellent bonus and benefits
across their entire business. As part of this growth, the business is looking to hire an experienced
Regulatory Affairs Strategist Jobs
By Navitas Life Sciences At , Remote
Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines
Support delivery in performing project management activities or as an individual contributor for a deliverable, managing relationships with all stakeholders
Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
There is a travel requirement of up to 10%
Knowledge of IND/NDA/BLA submissions and life cycle submissions for the US market
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
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 Associate Jobs
By Earth Animal At Southport, CT, United States
Identify claims issues and lead/offer alternatives to comply with regulatory guidelines while supporting business needs.
Must be a solution oriented, self-starter with demonstrated problem solving skills.
Skilled in Excel and demonstrate accuracy with collecting and analyzing data.
Responsibilities include but are not limited to:
Lead regulatory functions and collaborate with cross-functional partners in support of the marketing review and documentation proofing process.
Regulatory Claim Subject Matter Expert (Marketing Support and Review)
Regulatory Affairs Associate Jobs
By Aditi Consulting At Plainsboro, NJ, United States
Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.
Reports to labeling management in Regulatory Operations and Innovation.
Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).
May be responsible for managing projects, processes, or programs with manager oversight.
Experience and/or Familiarity with Structured Content is preferred
Excellent verbal and written communication and skills.
Associate Iii, Regulatory Affairs
By Sandoz At , Princeton $97,600 - $146,400 a year
Effectively monitor and track information and requirement changes
Maintain compliance with regulatory requirements and regulatory databases for generic drugs for the US market.
Adhere to all health, safety & environmental (HSE) requirements in support of departmental and site HSE goals
Excellent oral and written communication skills
Pharmaceutical or generic drug experience in a regulatory capacity
Lab experience and familiarity with Abbreviated New Drug Application (ANDA) and/or Electronic Common Technical Document (eCTD)
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
Clinical Affairs Scientist Jobs
By MDC Associates, Inc. At Beverly, MA, United States
Knowledge of applicable protocol requirements as provided in company training
Study sites and clinical study management
Provide input on content of submission documents based on experience, regulations and guidance available from regulatory bodies
Bachelor's degree in a health care or other scientific discipline or educational equivalent
5-10 years’ experience in a clinical environment or medical devices industry, with specific experience in in vitro diagnostic devices
Knowledge of the European Commission Medical and In Vitro Diagnostic Device Regulations.
Director Of Regulatory Affairs
By Tabseer | تبصير At Dallas, TX, United States
-Thorough knowledge of relevant regulatory laws, guidelines, and industry standards in Products Certification and Inspection Activities.
-Excellent communication and negotiation skills to articulate regulatory requirements and advocate on behalf of Tabseer.
-Good relationship with top level of Saudi Regulators’ Management Team.
Job Title: Regulatory Affairs Manager
-Clarify any ambiguous regulatory points or requirements by engaging with regulators and coordinating with internal teams.
-Stay informed about changes in regulatory landscape and assess their impact on Tabseer's certification and inspection operations.

Are you looking for an exciting opportunity to join a dynamic team in Regulatory Affairs? We are looking for a Regulatory Affairs Scientist to join our team and help us develop and maintain regulatory strategies for our products. You will be responsible for preparing and submitting regulatory documents, interacting with regulatory agencies, and providing regulatory guidance to internal teams. If you have a passion for regulatory affairs and want to make a difference, this is the job for you!

Overview Regulatory Affairs Scientists are responsible for ensuring that products meet all applicable regulatory requirements. They work with regulatory agencies to ensure that products are safe, effective, and compliant with all applicable laws and regulations. They also provide guidance to other departments on regulatory requirements and provide support to the development of new products. Detailed Job Description Regulatory Affairs Scientists are responsible for ensuring that products meet all applicable regulatory requirements. They work with regulatory agencies to ensure that products are safe, effective, and compliant with all applicable laws and regulations. They also provide guidance to other departments on regulatory requirements and provide support to the development of new products. They review and analyze product information, such as labels, packaging, and advertising, to ensure compliance with applicable regulations. They also review and analyze clinical trial data and other scientific data to ensure that products meet safety and efficacy requirements. Regulatory Affairs Scientists also work with regulatory agencies to obtain approval for new products and to ensure that existing products remain compliant with applicable regulations. Job Skills Required
• Knowledge of applicable laws and regulations
• Ability to interpret and analyze scientific data
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong organizational and problem-solving skills
• Attention to detail
Job Qualifications
• Bachelor’s degree in a scientific field
• At least two years of experience in a regulatory affairs role
• Knowledge of applicable laws and regulations
• Ability to interpret and analyze scientific data
• Excellent communication and interpersonal skills
Job Knowledge
• Knowledge of applicable laws and regulations
• Knowledge of clinical trial data and other scientific data
• Knowledge of product labeling, packaging, and advertising
• Knowledge of product development processes
Job Experience
• At least two years of experience in a regulatory affairs role
• Experience working with regulatory agencies
• Experience in product development
Job Responsibilities
• Review and analyze product information to ensure compliance with applicable regulations
• Review and analyze clinical trial data and other scientific data to ensure that products meet safety and efficacy requirements
• Work with regulatory agencies to obtain approval for new products and to ensure that existing products remain compliant with applicable regulations
• Provide guidance to other departments on regulatory requirements
• Provide support to the development of new products