• Login / Signup
    • Instagram
    youtube
    Facebook

    Director Of Regulatory Affairs (Nuvig Therapeutics)

    Work In Biotech
    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!

     

    Latest Jobs

    Lead Exec - Gbs-Emq

    Apotex
    Mumbai

    Trainee - Quality Stability Data

    Apotex
    Mumbai

    Senior Analyst - Quality - Apqr

    Apotex
    Mumbai

    Senior Manager, Qa(Compliance & Risk Mgt)

    Apotex
    Bangalore

    Clinical Statistics Team Lead

    Sanofi
    Hyderabad

    Principal Biostatistician-Clinical Statistics

    Sanofi
    Hyderabad

    Manager - Heva (Evidence Synthesis)

    Sanofi
    Hyderabad

    Rwe Data Analyst

    Sanofi
    Hyderabad

    Manager Heva (Bp Support)

    Sanofi
    Hyderabad

    Senior Non-Clinical Statistician (Efficacy & Safety) - Regulatory Cmc

    Sanofi
    Hyderabad

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | Tempe | Tucson | Yuma |

    California :

    Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Storrs |

    D.C :

    Washington |

    Florida :

    Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Rockville |

    Massachusetts :

    Boston | Cambridge | Medford and Somerville | Rockland |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New York :

    Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Syracuse |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |

    Ohio :

    Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

    Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Wyomissing |

    Portugal :

    Lisbon |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Denmark :

    Copenhagen |

    Hungary :

    Budapest |

    Istanbul :

    Turkey |

    Serbia :

    Belgrade |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Tokiyo :

    Tokyo | Osaka |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Salt Lake City | London |

    Republic of Ireland :

    Limerick | Dublin |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Remote :

    Remote | Remote - Europe | Remote, USA | Switzerland |

    Makkah :

    Riyadh | Jeddah | Rabigh | Najran | Khulais |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |