Manager, Regulatory Affairs-Chemistry Manufacturing & Controls (CMC)

Regulatory Jobs; Irvine (CA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

AbbVie is seeking a Manager of Regulatory Affairs for CMC (Biologics Product Lead) to collaborate with internal and external partners and deliver regulatory strategies for INDs/CTAs and life-cycle management. The role requires preparing submissions and navigating agency interactions with limited supervision.

The position involves building relationships across RA CMC, R&D, and Operations, mentoring peers, and supporting cross-functional teams in a hybrid work environment with possible offices in

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• Advanced degree preferred. Certification a plus.

Responsibilities

• Prepares CMC regulatory product strategies with limited supervision.
• Prepares regulatory submissions, including IND/CTA applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
• Analyzes information impacting regulatory decisions and seeks expert advice as required.
• Reviews and revises submission documentation to present data and strategy to agencies.

Skills

Regulatory strategy

CMC submissions

Cross-functional collaboration

Mentoring

Education

Bachelor’s degree in pharmacy, biology, chemistry, 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 at

www.abbvie.com

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The

Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead

works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited 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 to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.

Responsibilities

• Prepares CMC regulatory product strategies with limited supervision. Prepares regulatory submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements and variations under limited 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 submission documentation to effectively present data and strategy to regulatory agencies under limited supervision
• Responds to global regulatory information requests under limited supervision.
• Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages, under limited supervision
• Manages products and change control with an understanding of regulations, agency guidance and company policies and procedures with limited supervision. Analyzes and approves manufacturing change records with limited supervision.
• Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment.
• Analyzes legislation, regulation and guidance and provides analysis to the organization under limited supervision
• Contributes to creation of white papers and policies to illustrate current regulatory thinking under supervision of manager. Participates in initiatives internal to RA CMC
• May act as a formal or informal mentor to others.

This position will work a hybrid work schedule (3 days in office) from the AbbVie Lake County, IL; Irvine, CA or Waltham, MA headquarters.

Significant Work Activities

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

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

• 6 years biopharmaceutical or related industry experience.

Preferred Experience

• 6 years biopharmaceutical RA, R&D or Operations experience including 3 years in regulatory affairs
• Experience working in a complex and matrix environment
• Strong oral and written communication skills