What are the responsibilities and job description for the Associate Director, Regulatory Affairs CMC - PAC DM (Onsite Hybrid) position at Initial Therapeutics, Inc.?
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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, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok.
Job Description
The Associate Director, RA CMC Post Approval Change Dossier Manager 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 individual 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.
Additional Responsibilities Include :
- 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).
This role is based at AbbVie's office in Lake County, Illinois and does require a weekly hybrid onsite schedule.
Qualifications
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.
This job is eligible to participate in our long-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, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https : / / 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
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Remote working / work at home options are available for this role.
