Associate Director Regulatory Affairs CMC - North America
Location:
Fort Washington , Pennsylvania
Posted:
April 02, 2017
Reference:
5851170110/2-en-us

Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director Regulatory Affairs CMC - North America, located in Skillman, NJ OR Fort Washington, PA.
 
 
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units:  Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products. 
 
This is a global role.  Under the supervision of the North American Director, and as a representative of the GRA organization:
  • Partner with R&D, QA, Operations, Business Units and others to develop regulatory strategies for submissions and product related activities.
  • Negotiate with regulatory agencies to establish submission strategies and gain approvals of applications.
  • Point of contact between regulatory agencies and J&J Consumer for chemistry, manufacturing and controls (CMC) related issues
  • Preparation, review, submission, approval and maintenance of CMC sections for regulatory filings (CTA’s, INDs, NDA’s/ANDA’s, 510k’s, MAA’s, variations, renewals, etc…)
  • Review post-approval changes and assess the regulatory impact on affected registrations.  Develop regulatory strategies and coordinate filings (e.g. NDA supplements, Variations) as appropriate.
  • Act as a liaison between regulatory agencies and J&J Consumer for chemistry, manufacturing and controls (CMC) related issues; point of contact for Health Authority reviewing chemists and supervisory chemists.
  • Sponsor with R&D leaders to refine/develop processes relating to regulatory submissions and regulatory aspects of product development. 
  • Train and educate colleagues with respect to regulatory requirements.
  • Assess compliance of product (formulations, manufacturing processes, packaging, specifications, etc.) with filings and propose CMC mitigation strategies.
  • Understands the regulatory landscape across an assigned area of business.
  • Evaluate and provide opinions regarding agency initiatives and support team efforts to prepare company responses as appropriate.
  • Propose strategies to resolve routine and more complex regulatory CMC issues
  • Represent company in industry organizations, seminars, workshops, etc. 
  • May be asked to manage CMC resources (internal and external) as needed to ensure business continuity, growth, and favorable regulatory compliance profile

Qualifications
  • A minimum of a Bachelor’s Degree in Chemistry, Pharmacy or related scientific field is required.
  • 8+ years of relevant regulatory CMC experience including: preparation of CMC sections for HA filings (Modules 2 and 3, CTD, e-CTD), maintenance and experience with global regulatory filings is required.
  • Working knowledge of regulatory requirements for various drug dosage forms including solids, semi-solids, solutions, sterile products, etc. is required.  Experience with devices is preferred.
  • CMC experience with small molecules desired.
  • Experience across one or more consumer product categories (drugs, cosmetics, devices) preferred.
  • Expertise regarding documents needed to support local, regional and global filing requirements is required.
  • Strong technical/science-based background (QA, mfg, lab, plant, etc.) highly desired.
  • Broad and thorough knowledge of GMP and regulatory compliance is required.
  • Travel up to 10% domestic and international may be required.
     
     
    BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
     
     

Primary Location
United States-New Jersey-Skillman
Other Locations
North America-United States-Pennsylvania-Fort Washington
Organization
J & J Consumer Inc. (6101)
Job Function
Regulatory Affairs
Requisition ID
5851170110

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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