J&J Family of Companies Associate Director Regulatory Affairs in Indianapolis, Indiana
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. We will consider a candidate working at a remote location in the United States.
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 for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
This position provides regional strategic implementation support for projects in one or more therapeutic areas. The position is responsible for working with the Regional Regulatory Leaders, local operating companies and global regulatory teams (GRTs) to implement/execute strategies for both products on the market and products under development to meet the goals of the compound development teams, global regulatory teams, regional teams and local operating companies.
Regional Regulatory Strategy Implementation
Drives and leverages cross-regional synergies and efficiencies
Responsible for the development of strategic implementation plans.
Understands regional and local requirements and advises the Global Regulatory Team (GRT), Compound Development Team (CDT) and regional teams on implementation issues pertaining to regional regulatory strategies.
Participates as a member of the project related GRT; supports the GRT in the implementation of regional input into compound development, registration and life cycle management.
Responsible for the implementation of the regional regulatory strategy, including the regulatory submission plans, in line with R&D, regional and local business objectives.
Understands how supply chain decisions impact registrations in the regions.
Develops and updates contingency plans for the execution of regional regulatory strategies and refines regional plans as new data become available
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, related to strategic execution.
Represents the regions and provides input on implications for regional & global regulatory strategy through participation in other product-related teams (e.g., submission teams, Labeling Working Groups, CTA Working Groups, response teams, clinical teams, etc.), and provides team leadership where appropriate.
Works with regional RA Intelligence providers (e.g. GRPI, Regional Regulatory Leaders, LOCs) to deliver knowledge management to the organization. Contributes to a strong knowledge management base (collection/sharing)
Health Authority and Operating Company Interactions
Basic understanding of worldwide health authorities and applicability of procedures to the regions
Participates in the preparation for meetings with regulatory agencies in the regions.
Liaises directly with Operating Companies, as needed, to support submissions to HA’s.
Responsible for the preparation and provides review and input on global, regional, and local documents for submission to Health Authorities in the regions.
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.
Works with the Regional Regulatory Leaders and GRT to develop regional marketing approval submission plans and timing.
Manages and tracks country-specific requirements for local submission purposes (e.g. legal and technical documents, RMP)
Responsible for submission tactical planning and timelines, including submission plans for the products’ life cycle, and communicates to relevant groups.
Ensures follow-up of regulatory dossier after submissions.
Oversees management of responses to questions asked by Health Authorities in a timely manner and in line with the product strategy.
Liaises with the Regional Regulatory Leaders to advise the GRT, and as needed, CDT and R&D functional representatives, on required documents and processes to support HA contacts and submissions.
On behalf of the regions, provides strategic input to CTA dossier content, scope and timing
Contributes to the management of product lifecycle submissions (e.g., PSURs )
Serves as member of the Labeling Working Group (LWG) to provide regional input on proposed CCDS & updates
Oversees development of labeling negotiation strategies for countries in the regions and development of supporting documentation for labeling.
Regulatory Input into Other Functions
Engages GRL, Regional Regulatory Leaders and selected LOC representatives to enable execution of regional strategies
Secures global resource deployment (e.g., Med Writing, Safety, PhD, Supply Chain) to ensure implementation of regional strategies.
Provides regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints
Role within the Regional Regulatory Affairs organization
Leverages TA, strategic, tactical, operational and procedural synergies and efficiencies across regions.
Facilitates interactions between regional and global functions where needed.
Analyses regional & HA feedback to foster adaptive learning.
Tracks progress for assigned projects and generates reports for management as required
Fosters and maintains ongoing communication and alignment with key stakeholders and business partners, including GRT, operational teams, regional teams and LOCs.
As a member of the Regional Strategic Implementation Group participates in setting of operational direction
Actively participates in other management and leadership activities
Actively participates or provides leadership for process development or process improvement.
Enhances engagement with regional teams through close proximity to R&D centers and global operational teams
Facilitates management with regional/global teams (as needed)
Coaches and mentors junior staff
Has cross-regional and cross-functional leadership responsibility
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
Minimum of 10 years professional experience required
Minimum of 7 years of direct regulatory affairs experience is required (different experience for PhD and MS Candidates will be considered)
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.
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
Working Conditions/Travel Requirements
Must be able to work flexible hours to accommodate early morning/late evening meetings/teleconferences with different time zones.
Position located in the USA: 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%
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-930 US Route 202 South
North America-United States, United States-Pennsylvania-Spring House, United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)