Director Regulatory Affairs Labeling
Director Regulatory Affairs Labeling
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
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Please note that this position is can be based in San Diego CA South San Francisco CA or Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.
Position Summary
The Director of Regulatory Affairs (RA) Labeling will lead the development of a cross-functional labeling strategy for products worldwide including providing expert input on labeling requirements and strategic guidance during label development facilitating cross functional labeling discussions with Labeling Management Team (LMT) and Executive Labeling Committee (ELC) and participating in label-related Health Authority negotiations. The Director will be responsible for the end-to-end labeling process including lifecycle management of labeling and artwork for all Acadia products both in development and on market. This will include management of internal global Company Core Data Sheet (CCDS) process labeling SOP initial draft label development managing label review and finalization process and managing post-approval labeling updates.
Primary Responsibilities
- Guide develop and author draft labeling text (e.g. USPI PPI Med Guide EU SmPC EUPIL) to support marketing applications and labeling update of approved package inserts to support product lifecycle management
- Define and implement a labelling review and approval process including documentation of label history LMT/ELC decisions and exceptions from CCDS to facilitate end to end global labeling process
- Ensure labeling strategy is aligned with overall regulatory and program strategy by working collaboratively with key internal stakeholders including but not limited to Regulatory Affairs Clinical Research Drug Safety Quality Commercial Medical Affairs Legal Manufacturing and Supply Chain
- Oversee or otherwise lead and facilitate cross-functional labeling and related forums and meetings such as LMT and ELC to support draft Label development
- Interact with Regulatory Strategy Lead to ensure timely submission and implementation of global labeling requirements that are consistent with the companys position in the CCDS and in compliance with local labeling requirements
- Effectively communicate the regulatory labeling strategy risks mitigations and overall plans
- Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations by FDA EMA and other applicable regulatory authorities
- Drive the development implementation and maintenance of policies and procedures for the creation and management of labeling and communicate to appropriate stake holders
- Oversees and/or manage the review QC and approval process for all product labeling components and CCDS
- Responsible for the development of labeling negotiations strategic plans. Manage the internal process for review and resolution of health-authority feedback on draft labeling. Participate in label-related Health Authority negotiation meetings
- Train and mentor other RA Labeling colleagues or cross-functional team members in various matters relating to RA labeling
- Other duties as assigned
Education and Experience
- Bachelors degree in a scientific discipline or related field; advanced degree (e.g. PharmD) preferred. Targeting 10 years of progressively responsible Regulatory Affairs experience and 8 years experience in global labeling. This includes thoroughly understanding global regulatory labeling requirements and strategic labeling planning. Must have significant experience in global prescription drug labeling U.S. EU Australia Canada Japan and Switzerland. An equivalent combination of relevant education and applicable job experience may be considered.
- Must have a strong track record of leading labeling content development through the regulatory submission and review process Health Authority negotiations resulting in product approval.
- Demonstrated experience in developing and executing complex and innovative global labeling strategies assessing & communicating risk/benefit to senior management and influencing organizational direction as it pertains to labeling negotiations with regulatory authorities.
- Thorough knowledge of US and international regulations as they apply to pharmaceutical drug development.
- Strong writing skills; able to process scientific data and effectively summarize into the appropriate detail for labeling content.
- Experience in organizational management including matrix management of senior professionals and higher- level project teams.
- Ability to work in a cross-functional team environment and a flexible team-oriented perspective.
- Demonstrated problem solving abilities and conflict resolution skills.
- Excellent verbal and written organizational and communication skills.
- Excellent transverse collaboration skills demonstrated ability to work effectively in cross-functional and/or global teams.
- Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
- Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
- Must be able to travel on occasion.
Physical Requirements
This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
#LI-HYBRID #LI-BG1
Required Experience:
Director
Employment Type
Full Time
