What are the responsibilities and job description for the Scientific - Global Regulatory CMC Manager position at Net2Source Inc.?
Job Description
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:Global Regulatory CMC Manager
Duration: 12 months
Location: New Brunswick, NJ
Pay: $75-$85/hr on w2
Job Description:
Responsibilities will include, but are not limited to, the following:
1. Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
2. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
3. Responsible for the global regulatory evaluation of CMC change controls with supervision.
4. Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
5. Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
6. Participate in global regulatory interactions with health authorities, with supervision.
7. Facilitate document review meetings and discussions.
8. Develop and maintain knowledge of regulatory environment, regulations and procedures.
Skills/Knowledge Required:
Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
Experience in drug development processes and post-approval requirements
Experience in developing CMC regulatory strategy
Experience in project management
Have a solution-oriented approach to problem solving
Ability to plan/prioritize work of group members and guide/develop others.
Ability to work on complex projects and within cross-functional teams with supervision
Excellent communication skills, both written and oral
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 inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith 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)
Title:Global Regulatory CMC Manager
Duration: 12 months
Location: New Brunswick, NJ
Pay: $75-$85/hr on w2
Job Description:
Responsibilities will include, but are not limited to, the following:
1. Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
2. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
3. Responsible for the global regulatory evaluation of CMC change controls with supervision.
4. Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
5. Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
6. Participate in global regulatory interactions with health authorities, with supervision.
7. Facilitate document review meetings and discussions.
8. Develop and maintain knowledge of regulatory environment, regulations and procedures.
Skills/Knowledge Required:
Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
Experience in drug development processes and post-approval requirements
Experience in developing CMC regulatory strategy
Experience in project management
Have a solution-oriented approach to problem solving
Ability to plan/prioritize work of group members and guide/develop others.
Ability to work on complex projects and within cross-functional teams with supervision
Excellent communication skills, both written and oral
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 inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith 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)
Salary : $75 - $85
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