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Manager, Regulatory Affairs, Pharmaceuticals

ClinChoice Inc
Fort Washington, PA
  • Posted: over a month ago
  • Full-Time
Job Description

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.

DUTIES & RESPONSIBILITIES:

As the Manager of Regulatory Affairs for Pharmaceuticals, you will have the opportunity to formulate and implement strategies to support multiple leading pharmaceutical 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. This role include both supporting strategy for a variety of clients and hands-on support for submissions when needed or requested by clients.

Key Responsibilities: 

Job Title: Manager, Regulatory Affairs, Pharmaceuticals

Employment Type: Permanent

Location: Fort Washington, PA (or 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. If you are interested in our position, please send your resume to ClinChoice-Career@klserv.com .

 

 DUTIES & RESPONSIBILITIES:

 As the Manager of Regulatory Affairs for Pharmaceuticals, you will have the opportunity to formulate and implement strategies to support multiple leading pharmaceutical 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. This role include both supporting strategy for a variety of clients and hands-on support for submissions when needed or requested by clients.

 Key Responsibilities: 

  • Lead client interactions and act as Subject Matter Expert on regulatory pharmaceutical and/or biotechnology projects.
  • Collaborate with internal staff to author and support submissions to achieve successful approvals of clinical trials and marketing applications (including INDs, CTAs, BLAs, MAAs, and NDAs_.
  • May include directly or indirectly supporting a variety of client projects and submissions.
  • Manage client timelines and expectations to ensure a positive client experience. 
  • Act as SME with deep knowledge of regulations for all aspects of pharmaceutical development including interpreting regulations and applying appropriate regulatory risk management strategies designed to identify potential risk, evaluate consequences, and provide solutions to address client needs. 
  • Ensure compliance with all appropriate government regulations, industry guidelines, and best practices.
  • In collaboration with regulatory colleagues globally, devise and implement global regulatory strategy and provide leadership oversight for clients’ projects.
  • Manage, oversee and/or prepare regulatory documents and submissions in accordance with clients’ requirements.
  • Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.
  • Mentor internal team across various regulatory projects.
  • Prepare client presentations as needed.

 

Experience & Qualifications:

 

  • Bachelor’s or master’s degree in a scientific field. 
  • At least 5 years of regulatory experience in Regulatory Affairs for pharmaceutical and/or biotechnology products; experience with Phase 1 through Phase III products is highly desirable.
  • Experience supporting regulatory writing and electronic submission.
  • Experience supporting regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs.
  • Direct experience working with the FDA and other health authorities is highly desired.
  • Strong working knowledge of Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations is highly desired.
  • Must be able to interpret trends in the US healthcare regulatory environment.
  • 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

ClinChoice Inc

Address

Fort Washington, PA
19034 USA

Industry

Government

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