Manager, Regulatory Affairs - Consumer Products (Remote)

About ClinChoice

ClinChoice is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. ClinChoice was established in the US in 1995, and has grown to more than 2,000 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region. Please visit our website ClinChoice.com for our company information.

As the Manager of Regulatory Affairs for Consumer Products (Remote), you will have the opportunity to formulate and implement strategies to support multiple leading Consumer Product clients for various regulatory activities. The ideal candidate is a go-getter, exceptional communicator, and strategic thinker who thrives in a fast-paced environment with multiple demands and quickly becomes a trusted partner to their peers and clients alike.

Key Responsibilities:

  • Lead client interactions and act as Subject Matter Expert on Regulatory Consumer Product projects.
  • Manage client timelines and expectations to ensure a positive client experience.
  • Act as SME with deep knowledge of regulations for all aspects of Consumer Product development including interpreting consumer product regulations and applying appropriate regulatory risk management strategies designed to identify potential risk, evaluate consequences, and provide solutions to address client needs.
  • In collaboration with global regulatory colleagues:
    1. Devise and implement global regulatory strategies and provide leadership oversight for clients’ projects.
    2. Manage, oversee and/or prepare regulatory documents and submissions in accordance with clients’ requirements.
    3. Provide regulatory guidance on labeling and product claims.
    4. Provide regulatory global guidance with regards to regulation of a broad variety of consumer products including those regulated in the US by the FDA and the EPA.
  • Collaborate with internal staff to author and compile documents for submission to regulatory agencies.
  • Mentor internal team across various regulatory projects.
  • Monitor Regulatory environment and communicate any changes and impact assessments to all team members.
  • Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.
  • Prepare client presentations as needed.

Experience & Qualifications:

  • Bachelor’s or master’s degree in a scientific field.
  • At least 5 years of regulatory experience with a focus on consumer products.
  • Experience with a variety of consumer products (devices, drugs, and home care) is highly desired.
  • Direct experience working with the FDA and global health authorities highly desired.
  • Demonstrated ability to manage regulatory activities and deliver against project timelines.
  • In-depth understanding of the product development combined with experience in Quality Assurance, Clinical and Compliance is desired.
  • Must be able to interpret trends in the regulatory environment that directly affect business decisions in the consumer product industry.
  • Initiate and support development of digital technology solution for various processes across regulatory affairs/operations.
  • Established leadership and management skills with cross-functional teams in a matrixed organizational structure.
  • Strong leadership, strategic orientation, development of people, and process.
  • Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
  • Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
  • Must be comfortable with ambiguity in a small, fast-paced environment.

ClinChoice is an Equal Opportunity Employer / Committed to Diversity





PI140635318

Company
ClinChoice Inc
Posted
07/02/2021
Type
Full time
Salary Range
$92,000.00 - 158,000.00
per Year
Salary range estimated by
Location
Fort Washington, PA 19034, US