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Regulatory Affairs Specialist

3 months ago

Carlsbad, United States Novartis Full time

**Summary**:
Contributes and supports the development of submission of product registration, progress reports, supplements, amendments, and/or periodic reports. Supports all registration activities of the Department to ensure compliance with the requisites of the regional device regulatory environment.

**About the Role**:
**Major accountabilities**:

- Works closely with regulatory leads and consultants on delivering documentation for submission to regulatory agencies
- Acts as the main liaison with regulatory consultants to ensure compliance to regulatory guidelines for all submissions
- Plans and coordinates all activities associated with preparation of regulatory documents to ensure timely completion and submission of dossiers with adherence to timelines
- Reports technical complaints / adverse events / special case scenarios related to device within the required timelines
- Foster and maintain good relations with internal and external stakeholders

**Key performance indicators**:

- Project & stakeholder feedback
- Documents assembled and filed within timelines
- Adherence to Navigate policy and guidelines

**Minimum Requirements**:

- Bachelor’s degree in Biology, Chemistry, other science fields, or in the field of regulatory specialization
- Minimum 4 years of experience in a regulated environment
- Project management experience is a plus

**The pay range for this position at commencement of employment is expected to be between $102,400 and $153,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.**

**Commitment to Diversity & Inclusion**: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.**

**Required Skill Sets & Knowledge**
- Excellent written and verbal communications skills
- Strong organizational skills.
- Excellent attention to detail, critical thinking and analytical skills
- Understanding of aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes
- Working knowledge of and ability to prepare regulatory documentation in compliance with regional regulatory requirements
- Ability to multitask and manage multiple submission simultaneously

**Work Experience**:

- Functional Breadth.
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.

**Skills**:

- Analytical Skill.
- Clinical Trials.
- Collaboration.
- Detail Oriented.
- Lifesciences.
- Project Planning.
- Regulatory Compliance.

Division

Operations

Business Unit

Innovative Medicines

Location

USA

Site

Carlsbad

Company / Legal Entity

U441 (FCRS = US441) Navigate BioPharma Services, Inc.

Alternative Location 1

USA

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No