Johnson & Johnson
Director Regulatory Affairs – CMC North America Lead
- Experience 10+ Years
- Category Regulatory Affairs
- Location Fort Washington, PA Skillman, NJ
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director Regulatory Affairs – CMC North America Lead, in Fort Washington, PA or Skillman, NJ.
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. As a leader in the Global Regulatory Affairs (GRA) organization:
- Collaborate 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.
- 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 (HA) reviewing chemists and supervisory chemists.
- Preparation, review, submission, approval and maintenance of CMC sections for regulatory filings (CTA’s, INDs, NDA’s/ANDA’s, 510k’s, MAA’s, variations and 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.
- Influence R&D leaders to refine/develop processes relating to regulatory submissions and regulatory aspects of product development.
- Coordinate and lead meetings with Health Authorities.
- Train and educate colleagues with respect to regulatory requirements.
- Assess compliance of product (formulations, manufacturing processes, packaging, specifications, etc.) with filings and deliver CMC mitigation strategies.
- Manages compliance within the department by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
- Understands and moves to influence the regulatory landscape across an assigned area of business.
- Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company’s areas of interest and participates in influencing activities for regulatory reform in specific areas.
- Evaluate and provide opinions regarding agency initiatives and take lead to prepare company responses on CMC related proposals, as appropriate.
- Development and implementation of strategies to address complex regulatory CMC issues.
- Represent company in industry organizations, seminars, workshops, etc.
- Responsible for the management, leadership and professional development of a CMC team.
- Manage CMC resources (internal and external) as needed to ensure business continuity, growth, and favorable regulatory compliance profile.
- A minimum of a Bachelor’s Degree in Chemistry, Pharmacy or related scientific field is required.
- 10+ years relevant regulatory CMC experience including: preparation of CMC sections for Health Authority filings (Modules 2 and 3, CTD, e-CTD), maintenance and experience with global regulatory filings is required.
- In depth knowledge of regulatory requirements for various drug, device and combination products including broad dosage form experience including solids, semi-solids, solutions, sterile products, etc… is required
- Demonstrated people management and development experience is required.
- Demonstrated global/regional leadership is preferred.
- Experience across all consumer product categories (drugs, cosmetics, devices) is preferred.
- Broad and thorough knowledge of GMP and regulatory compliance is required.
- Experience working across time zones is required.
- Experience working with CRO’s is preferred.
- 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.