Director Of Regulatory Affairs (Nuvig Therapeutics)

10+ years

Not Disclosed

Redwood City

10 Oct. 2, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director, Regulatory Affairs

About Nuvig
Nuvig Therapeutics, Inc., headquartered in Redwood City, California, is a forward-thinking research and clinical development organization dedicated to transforming the treatment of inflammatory and autoimmune diseases. Our lead candidate, NVG-2089, is a recombinant human IgG1 Fc fragment designed to target immunomodulatory Type 2 Fc receptors, enhancing immune response modulation. We are also focused on engineering full-length therapeutic antibodies to tackle aggressive autoimmune diseases. Founded in 2021 by industry veterans and backed by top-tier investors, Nuvig is committed to advancing innovative therapies supported by substantial funding from investors such as Novo Holdings, Platanus, Bristol Myers Squibb, Digitalis Ventures, and Mission BioCapital.

Why Nuvig?

Join us in revolutionizing treatment options for patients with autoimmune diseases! Nuvig Therapeutics is developing novel immune therapies aimed at a wide range of autoimmune conditions, without the long-term side effects associated with existing treatments, such as immunodeficiency and increased cancer risk. As we advance our Development Candidate NVG-2089 into Phase 1b trials in early 2024, this is your opportunity to make a significant impact in an early-stage organization dedicated to improving patient care.

Position Summary

The Director of Regulatory Affairs will develop and implement global regulatory strategies across clinical, non-clinical, and CMC disciplines to support investigational studies. This key team member will report to the Head of Regulatory Affairs and ensure that regulatory strategies align with health authority requirements, while maintaining high standards for regulatory submissions.

Key Responsibilities

Lead program teams in preparing regulatory submissions, including briefing documents and IND/CTA filings.
Oversee responses to regulatory authority queries and manage critical clinical regulatory timelines.
Act as the primary regulatory representative for assigned projects during internal meetings and with regulatory agencies regarding clinical issues.
Maintain comprehensive knowledge of the global regulatory environment for cell therapies and regenerative medicine, including accelerated review programs.
Communicate evolving regulatory requirements and provide regulatory intelligence to support program needs.
Collaborate with external consultants, clinicians, and CROs to offer regulatory guidance.
Escalate issues affecting registration, regulatory compliance, and product lifecycle management to management.

Knowledge and Skills Required

Strong understanding of eCTD elements and structure, with excellent regulatory writing skills.
Proven knowledge of regulatory requirements for designing and conducting clinical trials and preparing regulatory submissions.
Preferred experience with Orphan Drug Designation and Breakthrough Therapy Designation.
Exceptional written and verbal communication skills.
Minimum of a Bachelor’s degree in a scientific discipline; advanced degree preferred.
Over 10 years of experience in the biopharmaceutical industry, with at least 8 years in regulatory affairs.
Knowledge of FDA and EU regulations is essential; experience with early development regulatory submissions is required.
Familiarity with biologics is preferred.
Ability to thrive in a fast-paced, start-up environment.
Experience directly writing submission documents for clinical trials and marketing applications is highly preferred.
Strong attention to detail and the ability to manage multiple responsibilities effectively.
Excellent organizational skills and the ability to prioritize tasks to meet deadlines.
Capability to work independently as well as collaboratively in a team setting.

What We Offer

A culture driven by our core values: patients first, teamwork, scientific rigor, and curiosity.
A collaborative, data-driven pre-IPO start-up environment that inspires excellence and focuses on advancing science for patients.
Learning and development resources for professional growth, with potential for advancement for high performers.
Competitive compensation, including a base salary, performance bonus, and stock options.
Comprehensive medical, dental, and vision insurance.
Health, Limited, and Dependent Care FSA; HSA with company contributions.
401(k) with company matching.
Pre-tax commuter benefits.
Paid term life and AD&D, STD, and LTD plans.
Employee Assistance Program (EAP).
Generous paid holidays and flexible PTO.
Flexible work schedule options (on-site/hybrid).
A kitchen stocked with a variety of healthy snacks and beverages.

Salary Range
The salary range for this position is $215,000 to $230,000. Nuvig considers various factors when determining compensation, including market data, experience, qualifications, and geographic location.

Join Nuvig Therapeutics and be part of a mission to make a transformative difference in patients' lives!

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Director Of Regulatory Affairs (Nuvig Therapeutics)

Job Description

Job Title: Director, Regulatory Affairs

Why Nuvig?

Position Summary

Key Responsibilities

Knowledge and Skills Required

What We Offer

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