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Senior Regulatory Associate

Description

RB is the world’s leading consumer health and hygiene company. We work with the best people to challenge conventional thinking and keep giving people innovative solutions for healthier lives and happier homes, through our brands.

A fantastic opportunity is available for a Senior Regulatory Associate to join our team in Parsippany, NJ. 

 

The Senior Regulatory Associate will manage CMC project assignments including managing or assisting in the coordination, review, compilation, assembly, filing and tracking of CMC sections of NDAs, INDs, Annual Reports and device 510k submissions and preparing, reviewing and submitting electronic drug and device establishment registrations and listings.  The Senior Regulatory Associate will also be responsible for providing CMC input for OTC drug monograph products and for medical devices and will support the regulatory activities in the global expansion of US products and US registration and launch of global products.

Provide Regulatory Support for Current Products and Development Projects
  • Provide CMC-related Regulatory support and input.
  • Deliver projects and other initiatives to progress current product portfolio by providing CMC-related direction and support to stakeholders.
  • Collect and compile CMC data required for registration submissions (Pre-approval and Post-approval).
  • Prepare CMC-related submission packages for the appropriate Regulatory Agency (e.g FDA, Health Canada).
  • Identify and complete GAP Analysis of submission package, communicate with management and R&D to resolve compliance issue.
  • Review Regulatory Formula Assessment for regulatory compliance checks
  • Review and assess relevant change controls (via Trackwise); maintain product compliance summaries (PCS) and ensure all necessary product-support documentation is accurate and prepared in accordance with agreed timings.
Implement New Regulations and Guidances
  • Assess impact of new CMC-related regulations and guidance documents.
  • Work with key internal stakeholders (e.g, R&D) to implement requirements within specified timelines.
  • Keep current with all relevant guidance documents and regulations while also monitoring any changes that occur which may impact currently marketed RB products.
  • Assess and communicate all CMC-related requirements to stakeholders in order to maintain compliance without delay to business due to Regulatory issues.
  • Work with Project Managers to adjust and monitor CMC-related timelines to support the business.
Support Infrastructure and Systems Integration
  • Contribute to supporting a high quality and effective infrastructure to meet the regulatory requirements which support the launch of associated RB products within North America (US & Canada).
  • Contribute towards infrastructure projects (processes, procedures, systems etc.) and provide CMC-related perspective.
  • Deliver project- and brand-specific activities assuring they are correct, complete and on-time including registrations, submissions, labeling/advertising initiation/reviews, etc.
Qualifications:
  • BS degree required at minimum.
  • Minimum of 4 to 8 years of OTC or Pharmaceutical (Rx) regulatory affairs CMC experience
  • Experience with IND, NDA Or ANDA compilation for CMC Sections (Module 3) is required
  • Experience working with FDA and Health Canada is highly preferred
  • Experience with electronic document management and submissions (e.g., eCTD) desired.
  • High attention to detail and strong organization skills.
  • Ability to establish close communications and working relationship with cross functional teams to meet business objectives.
  • Results oriented, entrepreneurial and self-motivated.
  • Willing to work in matrix, dynamic, fast paced environment. 
  • Excellent computer skills (Microsoft Office suite).
Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Job Segment: Medical, Medical Device, Healthcare

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