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 \xe2\x80\x93 Right Talent \xe2\x80\x93 Right Time \xe2\x80\x93 Right Place \xe2\x80\x93 Right Price and acting as a Career Coach to our consultants.

Title: Global Regulatory Affairs manager
Duration: 06 months (Extendable)
Location: Lawrence Township, NJ 08648
Job ID: 54685-1

Pay: $ 80 - 85/hr on w2
50% onsite - 50% remote

Position Responsibilities:

• Responsible for driving regulatory processes in line with business/R&D objectives to ensure timely registration of new products/line extensions and variation applications of CLIENT products.
• Responsible for interactions with Country Regulatory managers/regional leads regarding product registrations.
• Drives and support local projects and department related assignments.
• Responsible to keep up to date with the regulatory environment within the industry.
• Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases.
• Act as a key partner with the country Business function, Medical function, Clinical Operations function, Market Access function and Logistics function.
• Responsible for overall regulatory related topics for assigned products /therapeutic area.
• Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time.
• Manage, track, review regulatory deliverables from external partners in line with vendor manager.
• Represent GRS and/or GRS International on specific non-product related projects when input is required or when an opportunity arises.
• Interface between Global and Local, the GRM lead International Regulatory Teams engage the local GRS regulatory teams, communicate Project specific information (follow-up, update) to local teams, ensure alignment between registration/submission requirements and development plans, translate global regulatory expectations into local plans and lead the execution of these plans, digest and communicate Global Regulatory plans, including HA engagement plans to countries, digest and communicate results for key clinical trials, obtain aligned regulatory position, Represent and deliver the Global TA position, track the execution of the global submission plan.

Degree Requirements:

• Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary).

Experience Requirements

• 2-4 years of relevant experience expected , especially in Intercontinental region
• Demonstrated ability to break down complex, scientific content into logical components.
• Demonstrated ability to facilitate issue resolution.
• Demonstrated ability to organize / prioritize tasks.
• Understanding of tactical role of GRS in the drug development process.
• Understanding of general global regulatory requirements for drugs in development.
• Understanding of PD&C process and specific GRS responsibilities / deliverables at PD&C Decision Points for International

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.

Regards,
Sumit Kumar
Sr. Pharma Recruiter | Net2Source.Inc
(201) 750 3436 EXT 563
Sumit.kumar@net2source.com
#LSC1

Net2Source