About this role

Position Description

Senior Regulatory Affairs Specialist

Location

Remote

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Position Summary

This role supports end-to-end planning and delivery of global clinical submissions, assists with the creation and release of core regulatory dossier sections, and aids in the high-quality work to support ongoing clinical programs. The Senior Specialist, Clinical Regulatory Affairs will be a part of clinical program teams and will be working closely with a variety of functions which include Clinical Operations, Clinical Development, Safety, and CMC leadership.

Support Strategic Regulatory Leadership

Supports the Regulatory Affairs Department across multiple company-sponsored projects and, under supervision, leads the assembly of regulatory dossiers for review by senior Regulatory Affairs management. Contributes to the company’s research and development efforts to develop high-value therapeutics.

Support the company’s planned global clinical regulatory strategy by representing Clinical Regulatory at the functional team level and assist with clinical development milestones.

Support senior regulatory advisor(s) in clinical program teams and contribute to regulatory strategy discussions.

Stay abreast of the regulatory landscape and regulatory requirements. Communication regulatory challenges and possible mitigation strategies.

Represent Regulatory Affairs in functional team forums, providing decision-making support and regulatory insights to senior management.

Global Submission Strategy & Execution

Support the planning, authorship, review, and delivery of all major clinical regulatory submissions, including:

New Drug Application (NDA)

IND/CTA filings and amendments

Health authority pre-submission and post-submission packages

DSURs, Annual Reports, SUSAR submissions

Protocols, IBs, and related clinical documentation

Support or lead cross-functional submission teams with CROs, ensuring clarity of roles, timelines, and quality expectations.

Support the established and continuously optimize submission processes, tools, templates, and governance standards.

Core Dossier Management & Country Customization

Support the development, release, and lifecycle management of global core clinical dossiers, ensuring scientific rigor, regulatory compliance, and internal alignment.

Understand and aid the strategies for efficient global rollout, including harmonization across regions and scalable dossier architecture.

Contribute to executive-level guidance to regional teams on country-specific customization, ensuring adherence to local regulations, formats, language requirements, and health authority expectations.

Coordinate approvals of localized submissions for strategic consistency and regulatory integrity.

Collaborate with Regulatory Operations on archiving submission dossiers.

Clinical Operations Partnership & Trial Execution

Partner with members of the functional clinical program teams to ensure regulatory considerations are fully integrated into trial startup, conduct, and closeout.

Support regional feasibility and startup planning from a regulatory perspective, including country prioritization and risk management.

Assist with oversight of vendor and CRO performance related to regulatory responsibilities.

Support organization-wide inspection readiness and aid senior team members with oversight during audits and regulatory inspections.

Qualifications

Required

Bachelor’s degree in life sciences or related field.

8 years of experience in biotech/pharma, with a minimum of 4 years hands-on Regulatory Affairs experience handling drugs or medical devices.

Demonstrated knowledge of global IND/CTA submission types, dossier management, and regulatory interactions.

Basic knowledge of ICH GCP, global clinical trial regulations, and regional requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.).

Experience with communication to cross-functional leaders and supporting alignment on regulatory strategy.

Strong and dynamic communication and organizational skills.

Strong computer skills in Word, Excel and Adobe Acrobat, and working knowledge of electronic publishing/file management systems are an asset. Ability to use Internet for research applications is required.

Preferred

Experience with biologics, gene therapies, cell therapies, or other advanced modalities.

Prior experience with global clinical trials and rollout of core clinical dossiers or large-scale clinical submission programs.

Advanced degree, RAC certification, or equivalent credential.

Experience in fast-paced or emerging biotech environments.

Additional Information

Nektar currently anticipates the base salary for the Senior Specialist, Clinical Regulatory Affairs to range from $150,000 to $185,00 for candidates in the Bay Area and will depend, in part, on successful candidate's location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company's discretion on an individual basis.) The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

Health Insurance (Medical/Dental/Vision)

Disability Insurance

Holiday Pay

Paid Time Off (PTO)

401(k) Match

Employee Stock Purchase Plan

Wellness Programs

Parental Leave Benefits (in accordance with the terms of applicable plans)

For general information on company benefits, please go to https://www.nektar.com/careers.

[AD1]HR to update with appropriate salary band

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.

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