Senior Manager, Regulatory Affairs Device (Hybrid)

The Senior Manager Regulatory Affairs Device works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions including INDs/CTAs and amendments new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas Operations and Research & Development (R&D) organizations. Represents RA Device on teams such as product development Global Regulatory Product Teams and Operations brand teams to negotiate influence and provide strategic advice. This individual will support the Eyecare Therapeutic Area.

Additional Responsibilities Include:

• Prepares device regulatory product strategies. Prepares and manages regulatory submissions including new applications and amendments renewals annual reports supplements and variations and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
• Responds to global regulatory information requests.
• Develops strategies for device agency meetings manages preparation for agency meetings and manages content of pre-meeting submissions.
• Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
• Represents RA Device on teams such as the product development Global Regulatory Product Teams and Operations brand teams for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
• Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation regulation and guidance provides analysis to the organization.
• Develops implements and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA Device.

To be successful in this role you should have:

• Knowledge of the ISO/CE process and global product registration process. Experience with eCTD tools and EDMS applications. 
• Knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends to drive proactive initiatives to ensure compliance for Device/Combination Products.
• Understanding of device/combination product regulations 21 CFR Parts 3 4 GCP GLP 210/211 820 QSR (Design Control) European Medical Device Directives and Regulation (MDR/IVDR) ISO 13485 MDSAP technical standards CMDR SOR/98-282 TGA SR. 236:2002 ANVISA RDC No. 16 JPAL Ordinance 169 MFDS No. 219 ISO 14155 eCTD Module 3 ISO/IEC 62366 HE 74 device complaint handling/MDRs human factors testing device risk analysis (ISO 14971) and other global regulatory requirements for Allergans devices and combination products. 

This role is an onsite hybrid opportunity. The preferred location is AbbVies Irvine CA office. 

Qualifications :

• Required Education: Bachelors Degree in Pharmacy Chemistry Biology or Pharmacology Engineering or related subject.
• Preferred Education: Relevant advanced degree preferred. Certification a plus.
• Required Experience: 8 years pharmaceutical experience
• Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery R&D or Manufacturing.
• Experience developing and implementing successful global regulatory strategies and working in a complex and matrix environment. 
• Strong oral and written communication skills.

Note: Higher education may compensate for years of experience

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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No

Employment Type :

Full-time