Associate Director, RA CMC

BioSpace; Irvine (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie in the United States seeks an Associate Director Regulatory Affairs, CMC to collaborate with internal and external partners to deliver medicines to patients. You will prepare CMC regulatory strategies that enable first pass approvals and manage content for INDs/CTAs, amendments, new marketing applications and variations.

You will represent CMC within product development, Global Regulatory Product Teams and Operations, negotiating with authorities and guiding submissions to ensure

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
• Advanced degree preferred; Certification a plus.
• 8 years pharmaceutical experience with at least 3 years in leadership.
• 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing.
• Experience developing and implementing global regulatory strategies and working with Health Authorities.
• Experience in a complex, matrix environment.
• Strong oral and written communication skills.
• Higher education may compensate for years of experience.

Responsibilities

• Prepares CMC regulatory product strategies and manages submissions, including new applications and amendments, renewals and variations.
• Analyzes information affecting regulatory decisions and seeks expert advice as required.
• Reviews and revises regulatory submissions to present data and strategy to agencies.
• Develops strategies for CMC agency meetings and pre-meeting submissions; serves as contact for meetings.
• Manages change control and manufacturing change requests with regulatory understanding.
• Represents CMC regulatory affairs on cross-functional teams to maximize first-pass approvals.
• Stays abreast of regulatory procedures and guidance; analyzes legislation and provides insight.
• Develops and documents RA CMC policies; leads internal RA CMC initiatives.
• Trains and mentors individuals; may include supervisory responsibilities.

Skills

Communication skills

Regulatory strategy

Leadership

Education

Bachelor's degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject

Advanced degree preferred

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC 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 CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g., FDA) regarding CMC matters.

Responsibilities

• Prepares CMC 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


• Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.


• Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.


• Represents CMC regulatory affairs 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. Leads initiatives internal to RA CMC.


• Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.


• Trains, develops and mentors individuals; may include formal supervisory responsibilities

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 with at least 3 years of demonstrated leadership


• 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. Experience working with Health Authority.


• Experience 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 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 employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html