Johnson & Johnson Careers
Please enter a valid email.
Unfortunately, our network is not responding. Please try again later.
Your job alert was successfully created.
Manager Global Regulatory Affairs CV
Requisition ID: 4375180226
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Manager, Global Regulatory Affairs- to be based preferably in Raritan, NJ and will consider either Titusville, NJ or Spring House, PA.
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, Infectious Disease and Vaccines, Metabolic, Neuroscience and Immunology. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Manager, Global Regulatory Affairs, will provide support to the Global Regulatory Leader (GRL) for regulatory activities for Xarelto® (rivaroxaban). Key responsibilities include the following:
- Lead preparation, review and approval of regulatory documents as assigned.
- Assist GRL in maintenance of specific regulatory systems and tracking systems.
- Participate in global regulatory team meetings and advise the regulatory team on applicable regulatory requirements and project specific regulatory issues as assigned.
- Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area as needed.
- Assist in ensuring regulatory compliance with agreements as signed with external partners.
- Provide regulatory input on an as needed basis (eg: follow-up to inspections or audits).
- Serve as the Regulatory representative on specific cross-functional teams and provide regulatory viewpoints and expertise to teams (eg: CTA Working Group, Clinical Working Group or Label Working Group).
- Review protocols and clinical trial plans and ensure alignment with regulatory requirements, as assigned.
- Provide regulatory support (strategy and tactics) for global submission plans as assigned.
- Lead Rapid Response Teams (RRT) to respond to CTA Health Authority questions.
- Assist with timely availability of submission documents and ensure that all document components are in place on time.
- Draft and review some document content as needed.
- Understand application details and liaise with Submission Management (RSMO).
- Review and approve submission plans as needed. Review of some submission documents to ensure compliance with regulatory requirements.
- Assist with submission and acceptance of the submission package.
- Minimum of Bachelor’s degree and 8 or more years of relevant pharmaceutical experience is required.
- Minimum of 5 years pharmaceutical or health authority experience with knowledge of the drug development process and regulatory submission and approval process.
- Working knowledge of the regulatory environment, guidelines and practices as well as pre-and post-regulatory requirements.
- Experience in critically reviewing and compiling regulatory documents.
- Able to work successfully within a collaborative team environment and as an individual contributor.
- Able to prioritize and manage multiple complex tasks/projects within agreed timelines.
- Strong interpersonal and communication skills.
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-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)