Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA and we are hiring "Job Title" for one of our clients. We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to Start-ups across various verticals like Technology, Financial Services, Healthcare, Life Sciences, Oil & Gas, Energy, Retail, Telecom, Utilities, Technology, Manufacturing, the Internet, and Engineering.
Job Title: Senior Manager, CMC Regulatory Affairs, Biologics
Duration: 6 months (potential to extend)
Location: Remote/Foster City, CA 94404
Location: Remote but preference is to have a candidate available to be onsite at the Foster City, CA Gilead offices 2-3 days if possible
Responsibilities May Include
- Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. Ensure dossiers meet ICH and local regulatory requirements.
- Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the International markets.
- Liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
- Co-ordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets and execute filings according to agreed priorities.
- Maintain a current awareness of CMC registration requirements in each of the International regions and communicate key regulatory intelligence to the organization on a timely basis.
Knowledge, Experience And Skills
- BA/BS, MS or Ph.D or equivalent education.
- Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience.
- Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products.
- Biologics experience or drug-device combination product experience would be an advantage.
- A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
- Proven strategic thinking skills, with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously.
- An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
- Experience representing CMC regulatory affairs on regulatory and cross functional teams.
- Excellent written and verbal communication skills.
Required Years Of Experience
- At least 2 - 3 years of experience
Top 3 Required Skill Sets: Significant experience in CMC Regulatory Affairs; strong verbal and written communication skills; experience in leading and preparation of regulatory submissions
Top 3 Nice to Have Skill Sets: Experience with Veeva Vault, including RIM; global regulatory expertise
Unique Selling Point of this role: This role is a great opportunity to get experience in a CMC RA team, develop knowledge of Regulatory Affairs, and while working in data entry, may support the Team in other regulatory-related activities, such as supporting preparation of straight-forward submissions.
Required Degree Or Certification
B.A/B.S, MS or Ph.D or equivalent education
Any Disqualifiers?
Insufficient regulatory experience that prevents the candidate from acting as an effective lead for assigned product(s) and regulatory submissions.
About Net2Source, Inc.
Net2Source is a total talent management solutions company with its presence in 50+ countries. Our creative solution service offerings aim at becoming your one stop destination for hiring talent needs globally.
Want to read more about Net2Source? Visit us at www.net2source.com
Equal Employment Opportunity Commission
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
Net2Source Inc. is one of the fastest growing Global Workforce Solutions company with a growth of 100% YoY for last consecutive 3 years with over 4100+ employees globally and 30+ locations in US and operations in 50+ countries. With an experience of over a decade we offer unmatched workforce solutions to our clients by developing an in-depth understanding of their business needs. We specialize in Contingent hiring, Direct Hires, Statement of Work, Payroll Management, IC Compliance, VMS, RPO and Managed IT Services.
Fast Facts About Net2Source
- Founded in 2007
- 100% Minority Owned, Debt Free, Private
- 4100+ consultants globally
- 2550 consultants placed in the US
- 750+ team of in-house staffing team
- 30+ sales offices in the US, and 50+ Offices globally
- Operations in 20 countries (US, Canada, Mexico, APAC, UK, UAE, Europe, , Europe, Latin America, Japan, Australia)
Awards And Accolades
- 2020 Fast 100 Asian American Businesses by the US Pan Asian American Chamber of Commerce Education Foundation (USPAACC 2019)
- 2019 & 2018 Ranked 21st Fastest Growing Staffing Company in USA by Staffing industry Analysts
- 2019 & 2018 Fastest 50 by NJ Biz (Ranked (9th and 27th ).
- 2019 Top 100 Fastest companies to grow in Dallas by Dallas Business Journal.
- INC 5000 Fastest growing for 8 consecutive years in a row.
- America's Most Honored Businesses (Top 10%)
- 2019 Dallas Top 100 by Dallas Business Journal
- 2019 Proven Supplier of the Year by Workforce Logiq
- 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)
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