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    Regulatory Affairs Project Manager

    Spectraforce Technologies
    5-10 years
    $88/hr
    Remote, USA
    10 May 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Regulatory Affairs Project Manager

    Position Details:

    • Duration: 3+ Months
    • Location: Fully Remote (open to candidates in all US time zones)
    • Work Hours: Monday to Friday, 8 AM - 5 PM ET
    • Starting Pay: $88.00/hr

    Top Must-Haves:

    • Experience prepping for FDA advisory committee meetings.
    • Understanding of FDA questioning processes.
    • Ability to prep cross-functional leadership teams (Medical Directors, lead statisticians, lead of R&D) on presentation and responses.
    • Minimum 5 years of relevant Regulatory Affairs experience (regional and/or global).
    • Direct experience in US FDA Advisory Committee (ADCOM) Preparation.

    Preferred/Nice to Have:

    • Previous regulatory experience as a Consultant, Director, or Global Regulatory Affairs Specialist.
    • Advisory Board Experience.
    • Experience with Immunology products.
    • Potential travel to Washington DC for an advisory committee meeting in October.

    Job Description:

    • Accountability: Lead the development and execution of global regulatory strategies for immunology products in Early Development.
    • Responsibilities:
      • Formulate the Global Regulatory Project Strategy (GRPS).
      • Develop a global Health Authority (HA) interaction plan and strategy in collaboration with the Global Regulatory Team (GRT).
      • Communicate key outcomes to senior management.

    Education and Experience:

    • Required:
      • BS/BA degree in a relevant scientific discipline.
      • At least 8-10 years of pharmaceutical/biotechnology experience in R&D.
      • Minimum 5 years of relevant Regulatory Affairs experience (regional and/or global) in early development.
    • Preferred:
      • Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or related field).

    About SPECTRAFORCE

    Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. We offer talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services. Our services extend to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India, across various industries such as Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities, and Transportation.

    Our Philosophy:

    • Human Connection: Defined by our branding attitude of NEWJOBPHORIA®, bringing joy and freedom to the work lifestyle, enabling our people and clients to reach their highest potential.
    • Learn More: SPECTRAFORCE

    Benefits:

    • ACA compliant health benefits.
    • Dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances.
    • Commuter benefits, 401K plan with matching, and a referral bonus program.
    • Unpaid leave and paid sick leave as required by law.

    Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer. We do not discriminate against any employee or applicant based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other category protected by applicable laws.

    • Contact: For reasonable accommodation requests, contact Human Resources at LOA@spectraforce.com.

    At SPECTRAFORCE, we ensure fair compensation and wage transparency in compliance with all applicable state and local laws.

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