Associate Director, Regulatory Leader

Compensation

: $131,430.00 - $199,650.00 /year *

Employment Type

: Full-Time

Industry

: Executive Management



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Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Leader. The position will be based any one of the following US locations - Raritan, NJ, Titusville, NJ, or Spring House, PA or OUS locations - High Wycombe UK Beerse BE or Leiden NL.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

As the Associate Director, Regulatory Leader within the Established Products TA of Global Regulatory Affairs, you will provide strategic input into the global regulatory team (GRT) for North America (NA) [TM[2] and will lead and facilitate cross-functional activities related to regional strategy for a portfolio of marketed drug products within the Anti-Infective/Anti-fungal/Women's Health/Urology [TM[3] therapeutic area. Activities and responsibilities will include, but are not limited to:

* Develops and implements North American regulatory strategies throughout lifecycle of products that are currently marketed. Refines regulatory strategies as new data become available and re-assess as necessary.
* Builds and updates contingency plans for issues that affect registration scenarios and the continued lifecycle management of the product, and ensures strategy is in alignment with global regulatory strategy, Therapeutic Area portfolio, CMC-Regulatory Affairs strategy, commercial strategy, and the Target Product Profile.
* Works as the primary contact with US regulatory agencies on a daily basis.
* Leads the preparation of regulatory dossiers for submission to health authorities (HA). Provides input into and reviews submission documents to ensure that they are fit for purpose, supporting labeling statements as appropriate. Ensures that responses to HA questions are handled in a timely manner and in line with the approved product strategy. Defines, generates, and submits appropriate data-driven responses to NA regional HA questions. Manages lifecycle management submissions (including safety reports).
* Within the context of the global strategy, determines timing, appropriate NA regional strategy and content for all NA-based HA meetings. Prepares company personnel for interactions with HA. Interacts with local NA commercial operating companies on individual products / processes.
* Works with the Global Regulatory Team to provide input for target labeling, and the Labeling Working Group in making strategic decisions, including the creation of Labeling strategy. Reviews labelling to ensure adequate documentation supports the regional labelling text. Coordinate and follow-up variations and label update submissions to keep product compliance
* Ensures development and/or implementation of processes and procedural documentation to support compliance with HA and J&J requirements.
* Tracks information on submissions and approvals in collaboration with GLR, RRL and CMC group;
* Provides input into risk/benefit assessment; Work with GRT to direct, manage and resolve any \"issues\" as required with dedicated resources; Consult with Regulatory Legal and Healthcare Compliance to address pertinent issues.
* Provides global regulatory support and leadership on the product divestments and delistings. Oversees the document collection process to ensure timely but realistic responses for requests for regulatory information during the Due Diligence process and the development of a plan for MA transfers. Support interactions with external parties. [TM[4]

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Qualifications

QUALIFICATIONS:

* Minimum of Bachelors degree required preferably in a scientific discipline
* Advanced degree (MS, PhD, MD or Pharm D) is preferred;
* Minimum of 8 years of health regulated industry experience is required
* At least 4 years of relevant Regulatory Affairs experience required;
* Minimum of 4 years experience leading cross functional projects teams within matrix environment required;
* Wide range of experience in Regulatory Affairs and experience leading interactions with Health Authorities is preferred;
* Working knowledge of US/NA HA laws, guidance and regulations as it pertains to life cycle management (LCM) is required;
* Strong knowledge of product labeling strategies and associated HA regulations is preferred
* Solid understanding of biology and chemistry relevant to therapeutic area is preferred; Experience developing regulatory strategies and an understanding of product development required;
* Must be able to work successfully within a collaborative team environment, as an individual contributor and decision maker within a cross-functional organization.
* The ability to effectively prioritize assignments for multiple products and projects simultaneously is required
* Must be comfortable with both routine regulatory work as well as strategic and tactical elements in regulatory affairs.

This position will require approximately 10 % travel, both International and Domestic.

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.

Primary Location

United States-New Jersey-Raritan-

Other Locations

United States-New Jersey-Raritan, United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse, United Kingdom-England-High Wycombe, Netherlands-South Holland-Leiden

Organization

Janssen Research & Development, LLC. (6084)

Job Function

Regulatory Affairs

Requisition ID

00001EX0

Associated topics: administrative assistant, administrative officer, assist, asso, associate, beverage, chief operations officer, facilities, operation, records management * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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