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2 Source 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.
Sr. GPRD Lead Consultant Remote Contract The Sr GPRM works under limited supervision of the regulatory affairs (RA) program lead to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s). The Sr GPRM may act as the RA program lead on programs of limited complexity. The Sr GPRM is a member of the RA sub team and may lead or represent RA in regional or cross-functional teams. The Sr GPRM may act as subject matter expert and/or assume mentoring role.
Responsibilities Regulatory Strategy - Provides input to global program regulatory strategy, including regulatory designations & innovative approaches
- May provide global RA leadership for specific part of the program e.g. new indication, new formulation or act as RA program lead for program of limited complexity
- Coordinates regulatory readiness with other line functions, Country Organizations & Regions
- Represents RA or leads in regional RA or cross-functional activities
- Provides strategic input to cross functional deliverables (e.g. protocols, IB, safety reports etc)
- Contributes to the development and maintenance of the Core Data Sheet (CDS)
- Determines requirements and coordinates activities for Health Authority (HA) interactions. May lead HAs meetings together with RA program lead.
- May serve as local HA liaison (e.g., FDA or EMA).
Regulatory Submissions - Leads planning, preparation and submission of clinical trials.
- Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
- Coordinates, plans, and prepares for submission of initial registration and post-approval applications, including authoring of Module 1 documents
- Contributes to preparation, review and maintenance of local product information in their assigned region
- Leads regulatory activities during HA reviews including response to questions and HA interactions
Regulatory Excellence and Compliance - Ensures timely RA input and submission of regulatory compliance and maintenance reports (e.g. aggregate safety reports, annual reports, renewals, etc) across assigned regions
- Maintains regulatory information in compliance databases and document management systems
- May serve as RA subject matter expert
- May assume mentoring role
Life cycle management - In LCM, the Sr GPRM may report to the LCM-(Sr) GPRD, and focus on one of the following subject matter expertise:
- Maintenance: preparation of selected global regulatory submissions (eg Annual, aggregate safety reports, renewals, variations, etc.) for assigned portfolio
- Portfolio Transformation: portfolio streamlining activities eg. pruning and deregistration, divestment/integration, RxGx, portfolio transformation and manufacturing production transfer as applicable
- Business & Operational Excellence: Procurement of key components e.g. registration samples, certificates of pharmaceutical product CPPs, etc.in support to regional
- regulatory submissions
- For LCM Sr GPRM acting as Team Leads: Management of several direct reports, including talent recruitment, performance management and development of associates
Experience: - 4 years involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major region.
- Experience in leading cross-functional teams
- Strong collaboration, communication influencing and problem solving skills.
- Organizational awareness (e.g., interrelationship of departments, business priorities)
- Compliance and Quality mindset
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 the 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% of 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)
Warm Regards, Manu Janghala
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Fax: Address: 270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA
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