Senior Manager Global Regulatory Affairs

2 weeks ago

Los Angeles, California, United States EPM Scientific Full time $120,000 - $180,000 per year

A clinical stage biotech organization is seeking a
Manager/Senior Manager Global Regulatory Affairs
to supports multiple international regulatory initiatives across clinical-stage programs. This company is pioneering RNA interference-based therapeutics to address serious diseases with high unmet medical need. Its innovative platform enables targeted delivery to specific tissues, allowing for precise gene silencing and durable therapeutic effects.

The successful candidate will lead regulatory planning and submissions, ensure compliance with global regulatory standards, and collaborate cross-functionally to align strategies and timelines. This position offers broad exposure to regulatory operations and strategic development activities.

Key Responsibilities

  • Lead the preparation and submission of global regulatory documents (e.g., INDs, CTAs/IMPDs, annual reports, briefing packages).
  • Support or lead preparations for regulatory authority interactions.
  • Partner with global and regional regulatory teams, including external consultants, to support marketing authorization applications.
  • Develop and maintain submission plans, content outlines, and responsibility matrices to ensure consistency and completeness.
  • Track key milestones and deliverables to meet submission timelines.
  • Interpret and communicate regulatory requirements to ensure compliance across development activities.
  • Provide regulatory guidance to internal teams, with frequent collaboration with technical and clinical functions.
  • Review scientific and technical documentation for regulatory alignment.
  • Stay current with evolving regulatory frameworks and maintain internal knowledge resources.

Qualifications

  • BS or MS degree with 5+ years of hands-on regulatory experience, or
  • PharmD or PhD with 3+ years of hands-on regulatory experience.
  • Strong understanding of ICH and FDA guidelines, particularly related to device and combination product CMC aspects.
  • Experience managing complex projects in a matrixed, collaborative environment.
  • Excellent communication and negotiation skills across organizational levels.
  • Detail-oriented with the ability to work independently and within cross-functional teams.
  • Proven success in fast-paced, entrepreneurial settings.
  • Experience with international regulatory submissions.
  • Familiarity with tools such as Veeva RIM and SmartSheets.

  • Regulatory Affairs Specialist

    3 days ago

    Los Angeles, California, United States Astrix Full time

    We are seeking a detail-orientedRegulatory Affairs Specialistto support compliance and product approval activities within our food manufacturing operations. This role ensures that all products, processes, labeling, and communications meet applicable regulatory requirements and industry standards. The ideal candidate is proactive, highly organized, and...

  • Regulatory Affairs/Quality Assurance Manager

    4 days ago

    Los Angeles, California, United States Incrediwear Full time

    About Incrediwear Holdings Inc.At Incrediwear, we're revolutionizing recovery and performance with science-backed wearable technology. We want people to live life without limits We agree, it's a bold statement. Our innovative products are used by elite athletes, medical professionals, and everyday consumers worldwide to reduce pain, speed up recovery, and...

  • Director, Regulatory Affairs

    1 week ago

    Los Angeles, California, United States Brookfield Renewable Full time $100,000 - $150,000 per year

    Director, Regulatory AffairsWork Location: West (Remote)This position presents an opportunity to play a key role in a growth-oriented business that is a global leader in the renewable energy industry. This position is ideally suited to a knowledgeable, career-oriented individual seeking a challenging growth opportunity in renewable power.Reporting to the...

  • Senior Manager, Business Affairs

    5 days ago

    Los Angeles, California, United States GALE Full time

    GALE is a business agency that brings business insights to brand storytelling and activates it across every channel. With expertise in business strategy, media, CRM, addressable and brand communications, performance marketing, and technology, GALE creates integrated marketing systems and communications that grow businesses. Founded in 2014, the agency...

  • Senior Director, Business Affairs

    2 weeks ago

    Los Angeles, California, United States ESPN Full time $194,300 - $260,600 per year

    The Senior Director, Business Affairs, as part of the Original Content department, will be responsible for upholding the structure, negotiation strategy and business relationships for ESPN's original content portfolio; specifically related to the development, production, licensing and acquisition of ESPN's internal productions, as well as its award-winning...

  • Senior Director, Medical Affairs, Solid Tumors

    19 hours ago

    Los Angeles, California, United States Lyell Immunopharma Full time

    Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for...

  • Regulatory Support

    7 days ago

    Los Angeles, California, United States Axiom Software Solutions Limited Full time $80,000 - $120,000 per year

    Job Title : Regulatory SupportLocation: Basking Ridge NJ Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a monthRequirementsMandatory skills: • experience in pharmaceutical environment.• Experience in regulatory environment is required.• High level exposure or knowledge about FDA inspection and internal...

  • Director of Regulatory Writing

    1 week ago

    Los Angeles, California, United States iO Associates Full time $120,000 - $240,000 per year

    Director of Regulatory Writing (Biotech)Contract Duration:Up to 12 monthsRate:Up to $140 per hour (DOE)iO Associates is partnering with aclinical-stage biopharmaceutical companyadvancing innovative therapies for serious infectious diseases and oncology. The business is driven by a mission to harness the power of the immune system to improve patient outcomes....

  • Public Affairs Account Executive

    23 hours ago

    Los Angeles, California, United States Professional Search Group - OC Full time

    Professional Search Group OChas partnered with our client to identify anAccount Executiveto join their growing public affairs team.TheAccount Executiveplays a key supporting role across client accounts, helping to execute government relations, advocacy, and communications strategies. This position is ideal for someone with experience in or around the...

  • Sr. Manager, Global Media Partnerships

    7 days ago

    Los Angeles, California, United States PlayStation Global Full time $186,200 - $279,400

    Why PlayStation?PlayStation isn't just the Best Place to Play — it's also the Best Place to Work. Today, we're recognized as a global leader in entertainment producing The PlayStation family of products and services including PlayStation5, PlayStation4, PlayStationVR, PlayStationPlus, acclaimed PlayStation software titles from PlayStation Studios, and...