Associate Director, RA-CMC PAC DM

BioSpace; North Chicago (IL); On-site; USD 140,000 - 180,000; Full time

Job summary

AbbVie in North Chicago, IL seeks an experienced RA-CMC professional to lead post-approval change activities, coordinating cross-functional teams and authoring CMC sections for regulatory submissions.

You will coach junior staff, manage timelines, ensure CTD formatting, and collaborate across global programs. A strong regulatory background and leadership are required to succeed in this role.

Qualifications

• BA/BS in Chemistry or Biology is required.
• Minimum 8 years of pharmaceutical experience.
• 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing; 2+ years supervising staff.
• Experience preparing CMC sections of regulatory dossiers.
• Strong knowledge of CTD structure and manufacturing unit operations.
• Excellent communication and collaboration skills.
• Experience with electronic document management systems.
• Ability to work independently under pressure and manage multiple projects.

Responsibilities

• Independently manage, compile, and author CMC sections of marketed product variations.
• Develop content plans, bundling strategies, and project timelines with RA CMC leads.
• Collaborate with diverse groups to ensure file-ability of CMC sections.
• Manage projects to ensure thorough, accurate, and timely CMC dossiers.
• Lead programs across global initiatives for multiple post-approval changes.
• Ensure CTD content and formatting requirements are met; train on best practices.
• Provide tactical support to integrate technical issues with regulatory requirements.
• Identify content gaps and risks for variation documents.
• Provide guidance on submission document templates and updates.
• Support annual reports and renewals.

Skills

Chemistry/Biology degree

Pharma experience

Regulatory affairs experience

Supervisory experience

CMC documentation

CTD knowledge

Document management systems

Independent under pressure

Detail oriented

Collaborative mindset

US regulatory knowledge

Education

Chemistry/Biology degree

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
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
Individual is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will also ensure proper communication with all key partners in the functional departments in support of regulatory filings. This position will manage, coach, mentor, and develop junior staff, including new employee onboarding.

• Independently manage, compile, and author CMC sections of marketed product variations. Update moderately complex CMC documents independently.
• Independently develop initial content plans, bundling strategies, and project timelines. Partner with RA CMC Project Leads to verify and finalize as needed.
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Drive team and management reviews with minimal intervention by project lead. Provide coaching to more junior RA CMC colleagues during team and management reviews.
• Lead business critical programs through coordination of activities and resource management across global programs for multiple post approval changes.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met consistently across projects. Develop and communicate/train on best practices for use of regulatory business systems within the group.
• Independently provide tactical support to integrate technical issues with regulatory requirements and emerging standards.
• Identify and communicate content gaps and risks for variation documents.
• Provide usage team guidance and drive updates to submission document templates.
• Support annual reports and renewals (ad hoc baseline support).

Qualifications

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
• Required: 8 years pharmaceutical experience
• Preferred: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing, 2-plus years supervising employees
• Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions
• Strong working knowledge of manufacturing unit operations or CTD structure
• Superior oral and written communication skills
• Ability to work cooperatively with all levels and types of global personnel required
• Experience working with electronic document management systems
• Ability to work independently under pressure and manage multiple projects simultaneously
• Detail/accuracy oriented
• Collaborative and willing to learn
• Familiarity with US and other international regulatory requirements for drug product dossiers

Additional Information

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

• 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