Associate Director RA CMC Pipeline Hybrid Onsite
Associate Director RA CMC Pipeline Hybrid Onsite
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
The Associate Director Regulatory Affairs Chemistry Manufacturing and Controls (CMC) works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions including new marketing applications supplements and variations. Builds and maintains relationships within the Regulatory Affairs functional areas Operations and Research and Development groups. Manages products and change controls in compliance with regulations and company policies and procedures. Represents CMC on teams such as Product Development Global Regulatory Project Teams and Operations teams to negotiate influence and provide strategic advice. Serves as liaison and strategic partner with FDA. Manages assigned projects within assigned resources. May manage coach mentor and develop junior staff including new employee onboarding.
Responsibilities:
- Prepares CMC regulatory product strategies. Seeks expert advice regulatory intelligence and technical support as required for strategies and submissions
- Develops strategies for CMC agency meetings manages preparation for agency meetings and manages content of briefing documents
- Regularly informs regulatory management of important timely issues
- Manages preparation of CMC submissions. Prepares and manages regulatory applications including new applications and amendments renewals annual reports supplements and variations
- Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
- Identify and communicate content gaps and risks for submissions
- Manages change control in compliance with regulations and company policies and procedures. Analyzes and approves CMC change requests.
- Trains develops and mentors individuals; may include formal supervisory responsibilities
- Develops and implements policies and procedures within the regulatory affairs department
- Analyzes legislation regulation and guidance provides analysis to the organization
- Provides tactical support to integrate technical issues with regulatory requirements and emerging standards
This role is a hybrid onsite opportunity. The individual can be based in AbbVies Irvine CA Lake County IL or Florham Park NJ locations.
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 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.
US & Puerto Rico only to learn more visit ;
US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
