-
Regulatory Affairs Specialist
2 weeks ago
Genalyte San Diego, United StatesHere at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for a Regulatory ...
-
Regulatory Affairs Specialist
2 weeks ago
Adecco Permanent Recruitment San Diego, United StatesRegulatory Affairs Specialist · Salary Range: $90,000.00 To 110,000.00 Annually · About the Opportunity: · The Regulatory Affairs Specialist will work in conjunction with the Quality and Regulatory team to create, maintain and approve regulatory technical documentation, licensin ...
-
Regulatory Affairs Specialist
3 weeks ago
Cypress HCM San Diego, United StatesRegulatory Affairs Specialist · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clini ...
-
Regulatory Affairs Specialist
2 weeks ago
Adecco Permanent Recruitment San Diego, United StatesRegulatory Affairs Specialist · Salary Range: $90,000.00 To 110,000.00 Annually · The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have. · About the Opportunity: · The Regulatory Affairs Special ...
-
Principal Regulatory Affairs
3 weeks ago
Insight Global San Diego, United StatesAn employer is looking for a Principal Regulatory Affairs team member. This member would be responsible for 510K submissions and be responsible for developing regulatory strategies, preparing U. S. and major market submissions and obtaining approval to introduce new spinal implan ...
-
Regulatory Affairs Specialist
2 days ago
Genalyte San Diego, United StatesHere at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for a Regulatory ...
-
Regulatory Affairs Specialist
3 weeks ago
Genalyte San Diego, United StatesHere at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physicians office. We have a great opportunity for a Regulatory A ...
-
Regulatory Affairs Specialist
1 week ago
East Ridge San Diego, United StatesJob Description · Job Description · Eastridge Workforce Solutions is hiring a · Regulatory Affairs Specialist · for a company that offers cloud-based laboratory testing of blood tests through a central lab before releasing them to physicians for review and discussion with the ...
-
Regulatory Affairs Specialist
2 weeks ago
Argen San Diego, United StatesJob Description · Job Description · Regulatory Affairs Specialist · Monday – Friday, 8:30 am – 5:00 pm · About Us · At Argen, we're in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in Sa ...
-
Regulatory Affairs Specialist
3 weeks ago
Adecco Permanent Recruitment San Diego, United StatesRegulatory Affairs Specialist · Salary Range: $90,000.00 To 110,000.00 Annually · About the Opportunity: · The Regulatory Affairs Specialist will work in conjunction with the Quality and Regulatory team to create, maintain and approve regulatory technical documentation, licens ...
-
Regulatory Affairs Specialist
3 weeks ago
Argen San Diego, United StatesRegulatory Affairs Specialist · Monday - Friday, 8:30 am - 5:00 pm · About Us · At Argen, we're in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, G ...
-
Regulatory Affairs Specialist
1 week ago
Aequor Technologies San Diego, United StatesUS Regulatory Affairs Lead SCOPE OF RESPONSIBILITIES:' He/She will be responsible for representing regulatory function to approve promotional material' He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making working across ...
-
Regulatory Affairs Specialist
1 week ago
Genalyte San Diego, United StatesHere at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for a Regulatory ...
-
Regulatory Affairs Specialist
2 weeks ago
Aequor Technologies San Diego, United StatesUS Regulatory Affairs Lead · SCOPE OF RESPONSIBILITIES: · " He/She will be responsible for representing regulatory function to approve promotional material · " He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making wor ...
-
Regulatory Affairs Specialist
3 weeks ago
Adecco US, Inc. San Diego, United States**Regulatory Affairs Specialist** · Full Time · San Diego, CA, US · **Salary Range:** $90,000.00 To 110,000.00 Annually · Monday - Friday, 8:30 am - 5:00 pm · Who we Are: · A global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, G ...
-
Regulatory Affairs Specialist
4 days ago
Eastridge InfoTech San Diego, United StatesEastridge Workforce Solutions is hiring a · Regulatory Affairs Specialist · for a c ompany that offers cloud-based laboratory testing of blood tests through a central lab before releasing them to physicians for review and discussion with their patients, as well as providing con ...
-
Regulatory Affairs Specialist
4 days ago
Genalyte San Diego, United StatesJob Description · Job Description · Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have ...
-
Regulatory Affairs Specialist
2 weeks ago
Genalyte San Diego, United StatesHere at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for a Regulatory ...
-
Regulatory Affairs Specialist
1 week ago
Cypress HCM San Diego, United StatesRegulatory Affairs Specialist · Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding. · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissio ...
-
Regulatory Affairs Specialist
3 weeks ago
Eastridge InfoTech San Diego, United StatesEastridge Workforce Solutions is hiring a Regulatory Affairs Specialist for a c ompany that offers cloud-based laboratory testing of blood tests through a central lab before releasing them to physicians for review and discussion with their patients, as well as providing consultin ...
Director, Regulatory Affairs - San Diego, United States - ANAPTYSBIO
Description
AnaptysBio IncPlease ensure you read the below overview and requirements for this employment opportunity completely.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Description:
This position is responsible for the development and implementation of regulatory strategies for pipeline programs. This involves proactively identifying, assessing and mitigating regulatory risks to the plans.
Will share regulatory knowledge and insight that impact product and policy development by interpreting policy and industry trends, advising on agency interactions, and sharing regulatory lessons learned in order to help users navigate policy issues and minimize regulatory risks.
Essential FunctionsAccountable for the development and implementation of the regulatory strategy for AnaptysBio's pipeline programs.Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies to effectively negotiate regulatory agreements, and to ensure that all projects have clearly defined regulatory paths and milestones.
Manage regulatory project plans and timelines for projects in accordance with project, department and corporate goals.Keep abreast of all pertinent laws, regulations and guidance; develop aligned recommendations for regional regulatory strategies and implementation activities and share insights that impact product and policy development on a global level.
Develop and implement regulatory affairs practices and policies in compliance with quality systems, and to assure adherence to global and regional requirements, and SOPs.
Review protocols, reports and summary documents (clinical, pharmacology & toxicology) for adherence to regulatory guidelines, strategies, and commitments.Manage the assembly, support the review, and submission of, regulatory documentation such as INDs, CTAs, responses, etc. ensuring consistency/completeness/adherence to standards for all regulatory submissions.
Ensure the quality, content and format of regulatory submissions and for communication and teamwork with project team members.
Advise the project teams on applicable regulatory guidance's and other appropriate product regulations that impact the development of product candidates.
Interpret and advise the project team on the application of industry regulations, the FDA review process and international regulatory requirements.
Requirements:
Education & Experience:
BS in related scientific discipline, and 10+ years of experience in regulatory affairs. International experience is a plus.
Experience with Phase 1 through marketing application submission process.
Successful contribution to a major regulatory approval at a global or regional level preferred.
Experience in organizing and running successful FDA meetings.
Experience with multiple regulatory disciplines (CMC, clinical, labeling, etc.).Demonstrated leadership ability in team/department settings.
Proven leadership and program management experience.
Knowledge and Competencies:
A scientific and clinical understanding of the regulatory sciences.
Demonstrated understanding of regulations and guidelines governing drug development (particularly clinical drug development) including ability to apply these to overall strategic drug development.
Demonstrated ability in leading the development of sound and effective regulatory strategies. Identify and communicate potential risks associated with strategy scenarios.Knowledge of and experience with both US and international regulatory filings.
Experience with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Adobe, and Internet Explorer.
Effective communication and interpersonal skills, with the ability report and present experimental results and analysis to colleagues at all levels, including scientific/medical and management.
Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Ability to respond effectively to the most sensitive inquiries or complaints.Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well, with the additional ability of being able to build morale and group commitments to goals and objectives.
Ability to work productively in a matrix team environment, as well as take ownership of multiple projects.Ability to define issues, collect, and analyze complex data, and draw valid conclusions.
Ability to identify and resolve problems in a timely mannerAbility to develop strategies to achieve organizational goals; demonstrates an understanding of organization's situation and goals; analyzes market and competition; identifies threats and opportunities; adapts strategy to changing conditions.
Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Position will require domestic and international travel.Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
Work EnvironmentThe work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment.
The noise level in the work environment is usually moderate.
May be required to travel by plane or car.
This position requires working with biological and/or chemical hazards.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Compensation details:
Yearly Salary
PI433edf9c3a
#J-18808-Ljbffr
