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Senior Regulatory Affairs Specialist

LanceSoft, Inc.

Role overview

Qualifications

  • Bachelor's or master's Degree or equivalent
  • Regulatory experience in a highly regulated industry such as pharmaceuticals or diagnostics
  • Typically, at least 4 plus years relevant experience for entry into this level
  • Post-graduate certification and/or license may be required

Responsibilities

  • Develops and implements programs and processes to ensure compliance with regulations
  • Provides regulatory support for integration activities and reviews product labeling
  • Prepares document packages for regulatory submissions
  • Manages the changing regulatory environment and represents the company in external bodies

Key facts

Hard skills

Compliance Management Risk Management Regulatory Compliance

Other skills

  • Packaging And Labeling
  • Communication
  • Problem Solving
  • Teamwork

About the company

LanceSoft, Inc. logo

LanceSoft, Inc.

Staffing & Recruiting

Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele. As a Certified MBE and Woman-Owned organization, we pride ourselves on fostering global cross-cultural connections that advance both the careers of our employees and the success of our clients' businesses. At LanceSoft, our mission is clear: to leverage our global network to seamlessly connect businesses with the right talent and individuals with the right opportunities, all without bias. We believe in providing Global Workforce Solutions with a personalized, human touch. Our comprehensive range of services spans various domains, encompassing temporary and permanent staffing, Statement of Work (SOW) arrangements, payrolling, Recruitment Process Outsourcing (RPO), application design and development, program/project management, and engineering solutions. Currently, our team of over 5,000 professionals caters to 110+ enterprise clients worldwide, including Fortune companies. Our client base represents a diverse spectrum of industries, including Banking & Financial Services, Semiconductor/VLSI, Technology, Healthcare & Life Sciences, Government, Telecom & Media, Retail & Distribution, Oil & Gas, and Energy & Utilities. Headquartered in Herndon, VA, LanceSoft operates 32+ regional offices across the North America, Europe, Asia, and Australia. We also have nine delivery centers strategically located in India in Bangalore, Indore, Noida, Baroda, Hyderabad, Bhubaneshwar, Dehradun, Goa, and Aligarh to further enhance our client service capabilities.

Company details

Company typeXLarge
IndustryStaffing & Recruiting
Company size5001 - 10000

Links

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Job description

Enter Job Description...
  • Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.
  • Regulatory support for integration activities including reviews of product labeling and marketing materials for accuracy and compliance with regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
  • Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.
  • Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk.
  • Responds to customers’ and/or authorities’ requests/inquiries dealing with regulations and product compliance.
  • Represents company in external bodies dealing with standards and/or product regulations at the national/regional/global level.

The Ideal Candidate will have:

  • Bachelor's or master's Degree or equivalent.
  • Regulatory experience in a highly regulated industry such as pharmaceuticals or diagnostics
  • Typically, at least 4+ years relevant experience for entry into this level.
  • Post-graduate certification and/or license may be required.

EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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