Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category:Professional
All Job Posting Locations:Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America
Job Description:We are searching for the best talent for a Manager Global Regulatory Scientist, Regulatory Affairs. This hybrid work position will be in Beerse, Belgium, Leiden, Netherlands, High Wycombe/Maidenhead, UK, or Raritan, NJ and Spring House, PA (USA)
Job Description
Manager Global Regulatory Scientist, Regulatory AffairsKey Responsibilities:Under the direction of the GRL, RRL, your key responsibilities include the following:
- Draft cover letters and support the preparation of various applications ie: 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.
Qualifications Experience and Skills:- 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.
- opportunity to flex across different product types (pharma, devices, combo products).
- Knowledge of multiple global health authorities 'regulations and processes' would be ideal
- 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.
- 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. This role will include an opportunity to flex across different product types (pharma, devices, combo products).
- 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
Leadership Capabilities- 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.
- 10% domestic travel and potential international travel may be required for this position.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).
Belgium, Netherlands - Requisition Number:
R-088321United Kingdom- Requisition Number:
R-089114Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Required Skills:Preferred Skills: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
The anticipated base pay range for this position is :$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
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 Colorado -48 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
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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
