Regulatory & Medical Affairs - Regulatory CMC

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.Title: Regulatory CMC ContractorDuration: 05 monthsLocation: San Diego, CAPay:Job Description:The contractor will assist the Regulatory-CMC Cell Therapy team with projects to support department goals and objectives. Job Responsibilities require the following skills: Attention to detail, excellent organizational skills, good verbal and written communication skills are required. Ability to work independently on routine assignments with regular check-ins and to work cooperatively with senior staff providing key assistance on complex assignments. Computer experience must include familiarity with Word, Excel and PowerPointSupport Regulatory CMC Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND, CTA (IMPD), BLA, MAA applications.QualificationsMust have 5+ years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 1-3 years of Cell Therapy or Biologics Regulatory CMC experience, including the preparation of Cell Therapy or Biologics CMC dossiersAt least a bachelor s degree required.Skills/Knowledge Required:Experience with Cell Therapy or Biologics CMC regulatory documents (IND, IMPD, amendments, meeting requests and briefing books, responses to questions)REQUIRED: Experience with CMC regulations for cell therapy or biological compoundsA PLUS: Experience with Cell Therapy CMC regulationsREQUIRED: Practical knowledge of FDA, EMEA, Canadian, and ICH guidelines.A PLUS: Practical knowledge GMO or NSN applications, and of rest of world guidelinesREQUIRED: Have a solution-oriented approach to problem solvingA PLUS: Expertise in cell therapy or biologic drug development process activitiesREQUIRED: Ability to work on complex projects and within cross-functional teamsThe starting hourly compensation for this assignment is a range from - While the final, individual compensation will be determined by your employer of record (and not Client), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.Equal Employment Opportunity Statement:Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.Awards and Accolades: America's Most Honored Businesses (Top 10%) Awarded by USPAAC for Fastest Growing Business in the US 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020) Fastest 50 by NJ Biz (2020, 2019, 2020) INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list) Top 100 by Dallas Business Journal (2020 and 2019) Proven Supplier of the Year by Workforce Logiq (2020 and 2019) 2019 Spirit of Alliance Award by Agile1 2018 Best of the Best Platinum Award by Agile1 2018 TechServe Alliance Excellence Awards Winner 2017 Best of the Best Gold Award by Agile1(Act1 Group)#LSC1