Manager, RA CMC

BioSpace; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

Long-term incentive programs

401(k) plan

Job summary

AbbVie in North Chicago, IL is seeking a Manager, Regulatory Affairs for CMC to lead regulatory strategies and submissions, collaborating with RA, R&D and Operations to drive first-pass approvals. You will mentor teams and align products with evolving regulatory requirements.

Responsibilities include developing CMC strategies for INDs/CTAs and amendments, managing submission content, and building strong relationships with global agencies while guiding complex programs through lifecycle

Qualifications

• Bachelor's degree in a relevant scientific field is required.
• At least 6 years of biopharmaceutical or related industry experience.
• Experience in regulatory affairs within RA, R&D or Operations, including 3 years in regulatory affairs

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 and interprets information that impacts regulatory decisions; seeks expert advice as required.
• Reviews and revises regulatory submission documentation to present data and strategy to regulatory agencies.
• 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 supervision.
• Manages products and change control with an understanding of regulations and company policies under supervision.
• Represents CMC regulatory affairs on cross-functional teams to maximize chances for first pass approvals.
• Analyzes legislation, regulation and guidance and provides analysis under supervision.

Skills

Regulatory strategy

IND/CTA submissions

Cross-functional collaboration

Regulatory affairs

Written & verbal communication

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 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.

Purpose

Job Description

Describes the primary goals, objective or function or outputs of this position. The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) 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, with managerial oversight 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.

Qualifications

• Required Education: Bachelors 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 Responsibilities,
• Experience working in a complex and matrix environment
• Strong oral and written communication skills

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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, visithttps://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