Senior Associate, RA CMC

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

The Senior Associate, RA CMC works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations under management supervision. Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams.

Responsibilities

• Prepares CMC regulatory submissions under management supervision. Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements, and variations and responds to regulatory information under management supervision.
• 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 under management supervision.
• Manages products and change control with an understanding of regulations and company policies and procedures under management supervision. Analyzes and approves manufacturing change requests under management supervision.
• May represent 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 the regulatory climate. Maintains awareness of legislation and current developments within specific area of business

Qualifications

• Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• Preferred Education: Relevant advanced degree preferred. Certification a plus.
• Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management
• Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing
• 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 short-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 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.

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