Regulatory Affairs Lead

2 weeks ago

East Coast, Singapore Autolus Ltd Full time

With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced US Regulatory Affairs Lead to join the Autolus team to expand their cell and gene therapy products in the United States (US).
Key Responsibilities
- To provide strategic US regulatory input into clinical development and ensure the development and implementation of appropriate risk-based regulatory strategy and policies in line with the global regulatory strategy;
- To identify potential US regulatory risks to the strategic / operational plans and propose options to mitigate risks;
- To plan, prepare, manage and lead scientific advice meetings and other appropriate interactions with the FDA (e.g. pre-IND, pre-IDE, EOP1/2, pre-BLA meetings) to increase the predictability of regulatory outcome and to provide the best regulatory platform to support marketing approval and market access;
- To prepare high quality, detailed regulatory documents using varied information sources, engage in technical writing and gather prevalence and incidence data as appropriate;
- To draft US labelling in line with regulatory requirements and emerging data and lead negotiations with FDA;
- To perform regulatory review of essential documents, ICH GCP review of submission documentation e.g. protocol, IB, ICFs, labelling, human gene therapy protocols etc. and administrative activities such as eTMF filing;
- Ensure compliance with National/US Regulations and ensure awareness of cell and gene therapy guidelines across the company;
- Liaise with cross-functional team members in Translational Research, Product Delivery, Clinical Operations, Clinical Development, Project Management and external providers to ensure timely and effective regulatory submissions in support of product progression;
- To be responsible for development and training of US staff in regulatory matters and to communicate the impact of new regulatory requirements across the Company.

  • Regulatory Affairs Lead

    2 weeks ago

    East Coast, Singapore Autolus Full time

    **Location**: - US - East Coast**Job Summary**: Job Summary With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced US Regulatory Affairs Lead to join the Autolus team to expand their cell and gene therapy products in the United States (US). Key Responsibilities - To provide strategic US regulatory input into...

  • Director, Regulatory Affairs Promotional and

    2 weeks ago

    East Coast, Singapore Autolus Ltd Full time

    **Location**: - United States, East CoastKey Responsibilities - Regulatory Promotional and Medical Communication Strategy Development: Develop and implement a comprehensive regulatory strategy for advertising, promotion, and medical communication activities. Stay abreast of FDA and OPDP/APLB regulations, guidelines, and industry trends to ensure proactive...

  • Senior Manager

    6 days ago

    East Coast, Singapore Autolus Ltd Full time

    With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced CMC Regulatory Affairs Associate Director to join the Autolus team to work on innovative and pioneering products across Autolus’ cell and gene therapy portfolio. The Regulatory Affairs Associate Director will be part of the CMC regulatory affairs team with...

  • Regulatory Affairs Senior Engineer

    7 days ago

    Jurong East, Singapore Leica Microsystems Full time

    For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation...

  • Regulatory Affairs Principal Engineer

    7 days ago

    Jurong East, Singapore Leica Microsystems Full time

    For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation...

  • Project Coordinator

    6 days ago

    East Coast, Singapore Epista Life Science Full time

    Are you ready to #BeEpista? At Epista, you will grow a career in a setting that cherishes curiosity, integrity, and development. Epista Life Science is dedicated to defining and delivering process, technology and compliance excellence. Since our founding, we’ve expanded into multiple countries with big ambitions for the future. Our team is our superpower -...

  • Senior Business Consultant

    2 weeks ago

    East Coast, Singapore Emonics, LLC Full time

    **Position**:Senior Business Consultant** **Location***: **East Coast (Travel: 25%)** **Duration***: **Fulltime Position** **Job Description: - ** **Technical/Functional Skills** **-** **Experience-14+ years** - 15+ years of experience with pharma pre-clinical and clinical labs and relevant data management, biostatistical analysis, regulatory affairs -...

  • Senior Business Consultant Pharma Cmc

    1 week ago

    East Coast, Singapore Diverse Lynx Full time

    **Experience: 14+** 1. 15+ years of experience with pharma pre-clinical and clinical labs and relevant data management, biostatistical analysis, regulatory affairs 2. 10+ Years of experience with industry standard processes and solutions for CMC in labs direct FDA/EU regulatory experience is required. Experience with guidelines e.g. ICH is required. 3....

  • Senior Business Consultant Pharma Cmc

    1 week ago

    East Coast, Singapore Diverse Lynx Full time

    **Job Title: Senior Business Consultant Pharma CMC*** **Location : East Coast TCS locations*** **Travel: 25%*** **Experience: 14+*** 1. 15+ years of experience with pharma pre-clinical and clinical labs and relevant data management, biostatistical analysis, regulatory affairs 2. 10+ Years of experience with industry standard processes and solutions for CMC...

  • Business Consultant Manufacturing

    1 week ago

    East Coast, Singapore Diverse Lynx Full time

    **Experience: 7+** 1. 5+ years of experience with pharma manufacturing with clinical data management, biostatistical analysis, regulatory affairs or pharmacovigilance; if pharmacovigilance background, then familiar with enabling technologies like Veeva, Argus, Arisg, etc; if data management background, then experience in documenting, verifying, validating...