Lead Regulatory Scientist, Global Regulatory Affairs (Oncology) Full-time NEW

Lead Regulatory Scientist, Global Regulatory Affairs (Oncology)

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Janssen Research & Development, LLC is recruiting for a Lead Regulatory Scientist, Global Regulatory Affairs (Oncology). The preferred location is New Jersey or Pennsylvania.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

This position will support the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Oncology therapeutic area.

Key Responsibilities:

• Provide support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy
• Participate in global regulatory team meetings as appropriate
• Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
• Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
• Act as back-up for contact with Regulatory Agencies as needed
• Draft cover letters for Regulatory Agency communication
• Assist in the preparation of meetings with Regulatory Agencies
• Collaborate with Local Operating Companies (LOCs), and ensure responses to queries are made in a timely manner, and that content is consistent with the regulatory strategy
• Assist in the development and improvement of processes related to regulatory submissions
• Review clinical trial plans and protocols and ensure alignment with regulatory requirements
• Provide regulatory support throughout registration process and life-cycle management
• Advise team regarding required documents and submission strategies (in collaboration with LOCs as appropriate)
• Assist with timely availability of submission documents and ensure that all document components are in place on time
• Draft and review some document content (depending on level of regulatory knowledge/expertise)
• Prepare, hold and lead cross-functional team meetings as appropriate
• Understand submission details and collaborate closely with Submission Management
• Review and approve submission plans
• Review of submission documents to ensure compliance with regulatory requirements
• Assist with submission and acceptance of the submission package
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints
• Serve as the Regulatory representative on specific multi-discipline teams
• Stay on top of current and pending approvals in specific therapeutic areas and knowledgeable of laws, guidances and requirements related to those areas.

Qualifications:

Education:

• Bachelor's Degree plus 6 years of industry experience (required)
• Master level degree plus 4 years of proven experience (preferred)
• PharmD/PhD with 2 year relevant experience (preferred)

Experience and Skills:

Required:

• Previous health regulated industry experience
• Understanding of the drug development process
• Solid understanding of the regulatory submission and approval process
• Knowledge of US guidelines and practices in the regulatory environment
• Must be able to work optimally within a diverse team environment and as an individual contributor
• Project management, oral & written communication skills, organization and multi-tasking skills
• Teamwork skills, including effective communication and conflict resolution skills.
• Exercises strong organizational and time management skills
• Demonstrated ability of critical thinking and contingency planning with respect corporate objectives.
• Effective critical thinking including problem solving and goal setting for improved efficiencies.

Preferred:

• Direct experience in regulatory affairs is desirable
• Oncology Drug Development experience
• Regulatory, Clinical or R&D experience with products in early and late development stages
• Experience responding to FDA requests, handling FDA interactions, and lifecycle management of IND/NDA/BLA applications

Other:

• This position may require less than 10% travel.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is: $105,000-$169,050

Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time – 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time – up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below.