Director, Regulatory Affairs
Company: AnaptysBio Inc
Location: San Diego
Posted on: May 6, 2024
Job Description:
AnaptysBio IncAll 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 Functions
- Accountable 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
manner
- Ability 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. Reasonable accommodations may be made
to enable individuals with disabilities to perform the essential
functions.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: 156000-201000
Yearly SalaryPI433edf9c3a49-31181-34141996
Keywords: AnaptysBio Inc, Irvine , Director, Regulatory Affairs, Executive , San Diego, California
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