Johnson & Johnson Careers
Associate Director, Regulatory Affairs
Requisition ID: 3250190501
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for an Associate Director Regulatory Affairs to be based in Raritan, NJ, Titusville, NJ, or Spring House, PA.
INTERNAL CANDIDATES ONLY: Other in-house locations may be considered
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com and www.JanssenPharmaceuticalsInc.com for more information.
This position resides within Global Regulatory Affairs and provides regional regulatory strategic implementation support for products in one or more therapeutic areas. This person is responsible for collaborating with the Global and Regional Regulatory Leaders, functional area experts and Local Operating Companies to implement/execute the company’s regulatory strategies for both marketed products and products under development in line with R&D, regional and local business objectives. This person will function in a matrix environment and must exhibit strong leadership skills. Responsibilities include:
Regional Regulatory Strategy Implementation
- Responsible for the implementation of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.
- Represents the regions and contributes to the regional & global regulatory strategy through participation in product-related teams such as, Global Regulatory Teams, submission teams, Labeling Working Groups, CTA Working Groups, response teams, clinical teams, etc., and provides team leadership where appropriate.
- Advises product teams regarding regional and local requirements and impact of supply chain decisions on regional registrations to efficiently implement regional regulatory strategies.
- Leads the Regional Working group to ensure timely execution of product objectives and aligns regional deliverables with those of the global teams.
- Facilitates tactical implementation at the regional level and ensures ongoing and effective communications with the regional and global teams on product activities and issues.
- Leverages TA, strategic, tactical, operational and procedural synergies and efficiencies across regions.
- Provides regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints.
Health Authority and Local Operating Company Interactions
- Liaise directly with Local operating companies as needed and apply the understanding of worldwide health authorities and applicability of procedures to the regions to help in the preparation for meetings with regulatory agencies in the regions.
- Oversees management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.
- Responsible for development of regional marketing approval submission plans in collaboration with Regional and Global regulatory teams, development of tactical planning and timelines, including submission plans, review and preparation submission documents for the products’ life cycle, and communication to relevant groups.
- Responsible for the preparation of registration dossiers (e.g., International Common Technical Document (iCTD) and ASEAN Common Technical Document (ACTD)) and dossier re-use strategies.
- Manages and tracks country-specific requirements for local submission purposes (e.g. legal and technical documents, RMP).
- Oversees development of labeling negotiation strategies for countries in the regions and development of supporting documentation for labeling.
- A minimum of Bachelor’s degree (or equivalent) in a scientific discipline is required
- An advanced degree (MS, PhD, MD or PharmD) is highly desired
- A minimum of 10 years of relevant experience with a Bachelor’s degree is required OR Masters/PharmD 8 years; PhD 6 years is required
- A minimum of 7 years of Pharma regulatory experience with a Bachelor’s degree is required OR Masters/PharmD 6 years; PhD 5 years.
- Breadth of global regulatory affairs experience in global drug development and commercialized products (for example, experience in a therapeutic area, multiple phases of drug development) is required.
- Experience in the oncology therapeutic area would be preferred.
- Regulatory experience in at least one major geographic region preferred, with prior global regulatory exposure/experience.
- Experience specifically in AP, LA or non-EU countries is desirable.
- Good working knowledge of regulations and guidelines related to drug development and registration; Understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development; knowledge management skill and experience is desirable.
- Demonstrated contribution to drug development projects and implementation of strategies is desirable.
- Demonstrated ability to handle multiple projects, excellent verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to work in a matrix environment are required.
- Experience in working/leading project teams; demonstrated project management skills is required.
- Excellent English verbal and written Communication Skills
- Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones.
- Must be available for face-to-face meetings at all US sites, which may require travel to the NJ-PA R&D sites. Occasional overnight travel within US - less than 10%
- This position can be located in Raritan, NJ, Titusville, NJ, or Spring House, PA.
- INTERNAL CANDIDATES ONLY: Other in-house locations may be considered
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan-
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)