Associate Director Regulatory Affairs CMC - PAC DM Onsite Hybrid
Associate Director Regulatory Affairs CMC - PAC DM Onsite Hybrid
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Salary Not Disclosed
1 Vacancy
Job Description
The Associate Director RA CMC Post Approval Change Dossier Manager is responsible for ensuring RACMC 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 Responsibilties 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 fileability 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 AbbVies office in Lake County Illinois and does require a weekly hybrid onsite schedule.
Qualifications :
- Minimum of a BA/BS Degree in Chemical and/or Biological Sciences/relevant discipline required
- Required: 8 years pharmaceutical experience
- Preferred: 10 years pharmaceutical experience including 5plus years in regulatory affairs or 5plus years in Discovery R&D or Manufacturing 2plus 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 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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 AbbVies 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.
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 AbbVies 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.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
