Mgr Global Regulatory Scientist, Reg Aff
Johnson & Johnson, Spring House, PA, Hybrid
Regulatory Affairs ComplianceBachelor RequiredExecutive Director
About the role
About Innovative Medicine
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.
Learn more at https://www.jnj.com/innovative-medicine
Job Description
Manager Global Regulatory Scientist, Regulatory Affairs
Key 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-088321
United Kingdom- Requisition Number: R-089114
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.