Mgr Global Regulatory Scientist, Reg Aff

Johnson & Johnson Innovative Medicine•Spring House, PA

5d•$117,000 - $201,250•Hybrid

About The Position

This position is within the Regulatory Affairs Group and focuses on Regulatory Affairs. The role involves supporting the preparation of various regulatory applications and procedures for agency submissions, ensuring alignment with regulatory requirements, and providing regulatory support throughout the registration process. The Manager Global Regulatory Scientist will advise on required documents and submission strategies, assist with the availability and submission of Marketing Authorization Applications, and ensure country-specific submission packages are prepared. The role also includes assisting in the preparation of meetings with Regulatory Agencies, coordinating responses to queries, and liaising with Local Operating Companies (LOCs). The position may act as a backup contact on multi-discipline teams or with regulatory agencies, and may be responsible for organizing and leading meetings. Additionally, the role provides regulatory input for inspections, audits, litigation support, and product complaints, and supports global regulatory teams by driving project management for submissions and health authority interactions. The role also involves participating in global regulatory team meetings, assisting in strategy development by researching regulatory and medical information, and advising the regulatory team on applicable requirements and project-specific issues. Collaboration with regulatory colleagues to understand the competitive landscape, including health authority views, regulatory precedents, labeling differences, and disease area-specific issues, is also a key aspect. The role may also assist in the development and improvement of regulatory processes.

Requirements

A Bachelor's degree in scientific or equivalent discipline; advanced scientific degree is preferred, and at least 6 years of health regulated industry experience, or a Master’s degree and a minimum of 5 years of health regulated industry experience or a PhD/PharmD with a minimum of 4 years of health regulated experience.
At least 4 years of relevant regulatory affairs experience in pharmaceutical/biotech industry is required.
Solid understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, life cycle submission management and product labeling is required.
Experience preparing responses to health authorities, managing Health Authorities interactions, and life cycle management of clinical trials and marketing authorizations submissions (ie: IND/CTAS/NDA/BLA, MAAS other).
Experience in strategic planning, technical data summary and cross functional management is required.
Strong organizational and time management skills.
Strong collaboration skills, including effective communication and conflict resolution skills.
Strong leadership capabilities and ability to work successfully in a matrixed environment.
Effective critical thinking, including problem solving and goal setting.
Demonstrated ability to think strategically and contingency plan in order to meet business objectives.

Nice To Haves

Knowledge of multiple global health authorities ‘regulations and processes’ would be ideal.
Therapeutic area experience in oncology is beneficial.
Experience with combination products (drug and devices), would be an asset.
Intellectual curiosity and an ability/flexibility in learning new things and working in novel areas with limited regulatory precedence.
Analytical Reasoning
Business Writing
Coaching
Compliance Risk
Fact-Based Decision Making
Industry Analysis
Legal Support
Process Improvements
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Strategic Thinking
Technical Credibility

Responsibilities

Draft cover letters and support the preparation of various applications (IND, CTA, MAA/NDA and eCTD), and procedures for Regulatory Agency submissions.
For CTA/INDs – Ensure protocols are in alignment with regulatory requirements and provide advise on required documents and submission strategies in preparation for those filings.
For Marketing Authorization Applications (NDA, MAA or other major HA submissions): Provide regulatory support throughout registration process.
Advise team on required documents and submission strategies in preparation of NDA, MAA (and other global filings) as assigned (in collaboration with LOCs as appropriate).
Assist with timely NDA, MAA (other) availability, ensure that all document components are in place on time, identify and track critical path activities.
Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other).
Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.
Assist in the preparation of meetings with Regulatory Agencies. Coordinate, contribute to development, and review the content of responses to queries from HAs to ensure high quality and timely responses. May include other activities as delegated by the RRL/GRL.
Liaise with LOCs, track dates of submissions/responses to queries in a timely manner.
Acts as back up contact/representative on specific multi-discipline teams, or with regulatory agencies as needed. May be responsible for organizing and leading meetings.
Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.
Supports GRL(GRT) by driving high project management planning of global submissions or Health authority interactions and additional major regulatory milestones.
Participate in global regulatory team meetings as appropriate.
Assist in strategy development by researching regulatory and medical information in preparing submissions to Global Health Authorities (HAs).
Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned.
Partner with regulatory colleagues understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences, and disease area-specific issues.
May assist in the development and improvement of regulatory processes.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (or 48/56 hours depending on state)
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
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year