Lead Regulatory Scientist

Janssen Research & Development, LLC is recruiting for a Lead Regulatory Scientist. The preferred location is Springhouse, PA or remote work may be considered on a case-by-case basis, if approved by the Company (US & CA).

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.

The Lead Regulatory Scientist provides support to 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 Immunology therapeutic area.

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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 closely with 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 in 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 liaise 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 is knowledgeable of laws, guidances and requirements related to those areas.

**Qualifications**

**Education**:

- Minimum of a Bachelor’s degree plus 6 years of relevant experience
- Master level degree plus 4 years of relevant experience
- PharmD/PhD with 2 years of relevant experience.

Experience and Skills:
Required:

- Previous health regulated industry experience
- Understanding of the drug development process
- Understanding of the regulatory submission and approval process
- Knowledge of the regulatory environment, US guidelines and practices
- Project management, oral & written communication skills, organization, and multi-tasking skills

Preferred:

- Direct experience in regulatory affairs
- Regulatory, Clinical or R&D experience with products in early and late development stages
- Immunology Drug Development experience

Other:

- 10% domestic travel and potential international travel will be required for this position

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.

The anticipated base pay range for this position is $101, 500 to $142,000. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

**Primary Location**
United States-Pennsylvania-Spring House-Welsh & McKean Roads

**Other Locations**
North America-Canada-Alberta, North America-Canada-British Columbia, North Ameri