Associate Director, RA-CMC PAC DM

BioSpace; North Chicago (IL); On-site; USD 120,000 - 190,000; Full time

Job summary

AbbVie is seeking an experienced Regulatory Affairs professional to lead post-approval CMC submissions and manage CMC dossiers across global programs. You will author sections, coordinate with cross-functional teams, and coach junior staff.

You will develop content plans, ensure CTD formatting, and drive timelines while maintaining file-ability and regulatory compliance. Strong communication and project leadership are essential.

Qualifications

• BA/BS degree in Chemical, Biological Sciences or related discipline.
• 8 years pharmaceutical experience.
• Preferred: 10 years pharma experience including 5+ years in regulatory affairs or 5+ years in Discovery, R&D, or Manufacturing; 2+ years supervising employees.
• Experience in preparing CMC sections of regulatory dossiers including electronic submissions.
• Strong working knowledge of manufacturing unit operations or CTD structure.
• Superior oral and written communication skills.

Responsibilities

• Independently manage, compile, and author CMC sections of marketed product variations.
• Develop initial content plans, bundling strategies, and project timelines.
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
• Manage projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses; drive reviews with minimal intervention by project lead.
• Lead business-critical programs coordinating activities and resources across global programs for multiple post-approval changes.
• Ensure CTD content and formatting requirements are met; develop and train on best practices for regulatory systems.
• Provide tactical support to integrate technical issues with regulatory requirements and emerging standards.
• Identify content gaps and risks for variation documents and communicate them.

Skills

Regulatory leadership

Project management

Stakeholder communication

Detail orientation

Coaching

Education

BA/BS in Chemical or Biological Sciences

Tools

Electronic document management systems

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

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 or local 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

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