Regulatory Scientist Job Description
Regulatory scientist
provides strategic senior regulatory approval of the strategies, submissions plans, and HA interaction plans for these assets.
Regulatory Scientist Duties & Responsibilities
To write an effective regulatory scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory scientist job description templates that you can modify and use.
Sample responsibilities for this position include:
Developing bespoke regulatory data analysis reports and functioning analytical solutions based on staff requests using a combination of complex SQL, Excel, and technologies such as Python and R
Responsible for processing registration with the Ministry of Health for products exported to foreign countries
Ensure regulatory compliance of products, labels, advertising and promotions adherence to policies and guidelines
Contributing to the generation of technical documents required for REACH registrations, being responsible for successful completion of projects
Provide regulatory review of product labeling
The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills
Participating as an active member on the global regulatory team
Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy
Analyzing complex business and data analysis issues, identifying and proposing effective solutions and developing new, creative analytical methods and processes to mine Market Regulation’s regulatory data warehouses
Supporting vendor applications and proprietary tools used by department staff to ensure data is complete and accurate and users are able to maximize the utility and functionality provided by these systems
Regulatory Scientist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Scientist
List any licenses or certifications required by the position: USDA, FDA, RAC, WIPP, APHIS, HAZWOPER, OSHA, RWQCB, CESA, CDFW
Education for Regulatory Scientist
Typically a job would require a certain level of education.
Employers hiring for the regulatory scientist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Chemistry, Pharmacy, Biology, Nutrition, Engineering, Technical, Education, Biological Science, Health
Skills for Regulatory Scientist
Desired skills for regulatory scientist include:
Regulatory environment
Laws
US guidelines and practices
Guidances and requirements related to those areas
Assigned regional regulatory procedures and legislation
HA organizational structure and HA processes for reviewing submissions
Adobe and Internet Explorer
Annual reports
Excel
Experience with MS Project
Desired experience for regulatory scientist includes:
Experience in clinical drug development
Depending upon previous work experience, a new Senior Scientist may require close managerial oversight and guidance as they gain and accumulate knowledge and gain exposure to programmatic regulatory issues
Some experience in writing regulatory toxicology and/or environmental safety dossiers, experience in the design, implementation, and interpretation of studies evaluating in vivo toxicity or similar experience would be expected
Lab based role focused on development, validation and application of bioanalytical methods either for PK, ADA or Biomarker analysis
Work closely with the project bioanalytical representatives to ensure effective knowledge transfer of bioanalytical methods to CRO partners
Collaboration with colleagues in Braine and Slough to ensure methods are appropriately validated to support GLP studies
Regulatory Scientist Examples
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Regulatory Scientist Job Description
Job Description Example
Our growing company is looking for a regulatory scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory scientist
- Facilitating effective communication across all levels within the Market Regulation department and throughout the organization with regard to regulatory systems functionality and data
- Planning, designing strategy and executing laboratory based work packages to develop and perform immunological and biochemical assays for proteins that will, in turn, aid protein based discovery research, trait development, and/or support global deregulation
- Providing technical guidance to members of the Regulatory Science group, the larger GB community
- Authoring data summaries, including both GLP and non-GLP reports and presentation on research, publications, and intellectual property
- Maintaining broad knowledge of state-of-the -art principles, theories, and technologies relevant to protein research, in the current industry-standards for the scientific interpretation of the global regulatory requirements
- Serving as Study Director or Principal Investigator for GLP studies, writing and reviewing GLP Study Protocols and Final Reports, and interfacing with Study Sponsors to assure the protein safety studies meet the regulatory requirements
- Generating innovative new proposals that will advance research projects of Strategic Business units, and strong skills to present such proposals to management and/or key stakeholders
- Serving as the GB representative on any industry group related to protein safety
- Supporting a safety culture in which all accidents are preventable
- Excellent interpersonal skills, ability to be creative and motivated, while working closely with others in a team environment
Qualifications for regulatory scientist
- Actively contribute to ensuring GLP and GCP quality systems are compliant with regulatory requirements and robust scientific practice
- Actively promote transfer of scientific knowledge amongst peers and keep abreast of latest developments in regulatory bioanalysis including technologies and publications
- A minimum of 5 years’ experience working in the pharma or CRO industry supporting regulatory bioanalysis of NBE or biomarkers programs
- Hands-on knowledge of a range of bioanalytical techniques and platforms including but not limited to ELISA, MSD and Gyros to support the analysis of Pharmacokinetic and Pharmacodynamics endpoints including Anti-Drug Antibodies and Biomarkers
- Experience in autonomous method development and validation and transfer of novel methods for PK, ADA and Biomarker support
- Ability to troubleshoot immunoanalytical methods to ensure methods are fit for purpose
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Regulatory Scientist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of regulatory scientist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory scientist
- Ability to identify opportunities, establish plans, organize and commit to deliverables to drive success of projects of Strategic Business Units or to obtain regulatory approval for products
- Ability to determine whether and how to utilize internal or external technical resources
- Delivers project assignments supporting the business representation on functional workstreams
- Perform Regulatory Assessments on products and substances to ensure global compliance
- Provide support to compliance functions as needed (complete product forms, Prop 65)
- Perform impact analysis of federal and state legislation activities
- Provide advice to métiers and product development teams and give guidance on potential regulatory compliance issues
- Assist in the management of FDA OTC establishments
- Respond to inquiries regarding ingredients, formulations, regulatory issues and associated requirements
- Ensure consistent preparation of drug substance sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements, through the use of well-defined, efficient processes
Qualifications for regulatory scientist
- Experience in working with a wide range of internal stakeholders including Non-Clinical Safety, DMPK, Translational Medicine, Clinical Pharmacology, Clinical operations and Quality Assurance colleagues
- Well organized, capable of communicating clear instructions to partners and stakeholders alike
- Good knowledge of the English language both written and spoken, working knowledge of French is a plus
- Experience utilizing automation tools such as the Hamilton Starlet or other systems would be highly desired
- Provides support to the North American Regulatory Liaison (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy
- Participation in global regulatory team meetings as appropriate
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Regulatory Scientist Job Description
Job Description Example
Our growing company is looking to fill the role of regulatory scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory scientist
- Responsible for contributing to and implementing regulatory filing strategies
- Provide drug development experience and advice as appropriate to CMC teams
- Maintain awareness of global regulatory requirements on pharmaceutical development
- Serves as primary drug substance development interface with the CMC Regulatory group
- Assist CMC project teams in planning, preparation, review and approval of submission documentation
- Along with CMC Regulatory, assist CMC project teams in identifying submission-related risks and develop mitigation strategies
- Contribute responses to inquiries from regulatory authorities and interact with regulators during inspections
- Interface with CMC Regulatory personnel to ensure consistency across projects
- Preparing and updating CMC sections of IND/CTA for global submission of biological products
- Applicant will be responsible for multiple project assignments with critical timelines
Qualifications for regulatory scientist
- Advising the regulatory team on applicable regulatory requirements, and project-specific regulatory issues as assigned
- Act as back-up for contact with FDA as needed
- Provide regulatory support throughout registration process and life-cycle management
- Advise team in required documents and submission strategies
- Assist with timely availability of submission documents, ensure that all document components are in place on time
- Prepare, hold and lead cross functional team meetings as appropriate
4
Regulatory Scientist Job Description
Job Description Example
Our innovative and growing company is hiring for a regulatory scientist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory scientist
- Ensure position's alignment to Mondelēz International vision and values as its compliance to ISO 9001/14001 /18000/ 22000 quality, food safety, labour safety and security, environment, health and safety management systems‘ requirements
- Provides regulatory advice and interpretation of global regulatory requirements applicable to pre-market and commercial programs
- Ensures clinical activities are in compliance with global regulations and resolves complex regulatory issues
- Applies interpretation of regulations with respect to phase-appropriate clinical development
- Performs regulatory review of clinical documentation to ensure consistent writing style and formatting
- Assists in writing, reviewing, and editing clinical trial documentation, including clinical protocol, Investigator Brochure, and annual safety reports
- Reviews and critically analyzes clinical trial data and independently interprets and summarizes clinical results
- Performs literature searches and routine regulatory discovery work (researches regulations, guidelines, industry standards) related to preparation of clinical documentation for routine submissions and marketing approvals
- Provides regulatory input on marketing and patient recruitment materials
- Writes clear, user-friendly, product information leaflets and labels
Qualifications for regulatory scientist
- Troubleshooting and resolving technical issues associated to ligand binding assays as they arise
- Understand submission details and liaise with Submission Management
- Review and approve submission plans to ensure compliance with regulatory requirements
- A minimum of a Bachelor’s Degree with 6+ years of relevant industry experience is required
- An advanced degree (MS, PharmD or PhD) is preferred
- Previous experience in the Immunology therapeutic area is highly preferred
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Regulatory Scientist Job Description
Job Description Example
Our growing company is looking to fill the role of regulatory scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory scientist
- Is aware of internal and external business partners within food business
- Supports identification of claims
- Prepares all required official documentations for registration and commercialization in Russia (and Custom Union), including Halal certification wherever applicable
- Suggests, discusses with stakeholders and supports implementation of corrective measures when potential or actual non-compliance of a product is identified
- Provides regulatory and technical inputs into risk assessment process
- Trains others in core compliance related practices
- For routine actions acts by himself
- Plans, agrees with internal stakeholders and conducts efficient actions with external regulatory agencies and industrial groups
- Recommends improvements within R&D department
- Act as central point of contact internal and external to Global Stewardship for assigned products and projects, ensuring compliance from concept to finished product
Qualifications for regulatory scientist
- This position is located in Spring House, PA and may require up to 10% domestic and international travel
- Bachelor's degree in the life sciences, preferably with an MSc or PhD
- Minimum of two years' experience within the pharmaceutical/medical industry/CRO
- Broad working knowledge of the clinical drug development process with experience in integrating information from all phases of clinical development into clinical-regulatory documents/submissions
- Ability to work well with vendors
- Comprehensive knowledge of current regulatory guidelines relating to regulatory communications