Regulatory Affairs Manager
Il y a 6 mois
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for Manager, Regulatory Affairs to support the initiatives for the Interventional Oncology group (INTO). The position will focus on a range of novel product solutions to deliver solutions to treat cancers directly into the tumor.
**Key Responsibilities**:
- For CTA/INDs - Ensure protocols are in alignment with regulatory requirements and provide advice on required documents and submission strategies in preparation for those filings.
- For Marketing Authorization Applications (MAA or other major global HA submissions): Provide regulatory support throughout the registration process
- Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
- Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
- Assist with submission and acceptance of MAA and/or other global submissions as required
- Ensure country-specific submission packages are made available to the LOCs following 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, and track dates of submissions/responses to queries promptly.
- Acts as backup 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.
- Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
- Partner with regulatory colleagues to 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**:
**Qualifications, Experience and Skills**:
- A Bachelor's degree in scientific or equivalent discipline; an 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 the pharmaceutical/biotech industry is required.
- Knowledge of multiple global health authorities ‘regulations and processes’ would be ideal
- A 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 companion diagnostics, combination products and/or biomarker development, or medical devices is beneficial but not required
- Intellectual curiosity and an ability/flexibility to learn new things and work 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)
- Strong collaboration skills, including effective communication and conflict resolution skills.
- Effective critical thinking, including problem-solving and goal-setting.
- Proven ability to think strategically and contingency plan in order to meet business objectives.
10% domestic travel and potential international travel could be required for this position.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
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 t
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