Associate Director CMC Dossier Strategy and Leadership
Associate Director CMC Dossier Strategy and Leadership
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1 Vacancy
Job Description
Purpose
Describe the primary goals objectives or functions or outputs of this position.
Leads global regulatory dossier preparation activities by coordinating crossfunctional teams of subject matter experts from internal and external third parties. The primary function is to ensure consistent preparation of drug substance drug product and analytical sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Will implement welldefined efficient processes for preparation review and approval of these Chemistry Manufacturing and Controls (CMC) sections of submission documents. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory development strategy and provide drug development experience and advice as appropriate to the CMC team.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Author and coordinate submission documentation for all phases of clinical development with emphasis on later phase programs and marketing applications often under significant time pressure. Drive team resolution and author responses to questions from regulatory authorities.
- Leverage extensive drug development experience to lead the global crossfunctional CMC Team in completion of global regulatory submission documents. Maintain awareness of global regulatory requirements on pharmaceutical development. Ensure necessary changes to regulations are implemented in local practices and procedures.
- Demonstrate excellent interpersonal skills ability to develop important relationships with external collaboration partners and key internal stakeholders. Demonstrate strong negotiating influencing and leadership skills.
- Manages completion of CMC regulatory submission documentation for a limited number of projects of low complexity utilizing a matrix management approach. Individually completes submission document authoring and implements other creative approaches to conserve resources and achieve efficiency with respect to time and budget.
- Maintain expertise in the use of the eDocs submission documentation system and provide training and support as needed.
- Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Lead CMC project teams in planning preparation review and approval of drug substance drug product and analytical sections of CMC submission documentation.
- Partner with CMC Regulatory to assist CMC project teams in identifying submissionrelated risks and develop mitigation strategies. Provide local expertise in the use of eDocs.
- Coordinate document authoring and reviews with various groups outside of DPD such as Process R&D Operations S&T preclinical safety PK and QA.
- Interface with CMC Regulatory personnel to ensure consistency across projects. Represent the CMC team in communication of issues to DPD management.
- Maintain tools and templates to facilitate submission process. Make meaningful contributions to crossfunctional initiatives related to streamlining the regulatory submission dossier preparation processes.
Qualifications :
Qualifications
List required and preferred qualifications (up to 10). Include education skills and experience.
- Bachelors Degree with at least 68 years of CMC functional experience required; Masters Degree with at least 46 years of CMC functional experience preferred; PhD Degree with a minimum of 24 years of CMC functional experience highly preferred.
- Interdisciplinary experience required some analytical and/or formulation experience strongly preferred.
- Excellent computer skills with indepth knowledge of MS Office and the ability to quickly learn new computer software applications.
- Excellent scientific writing skills and working knowledge of regulatory requirements.
- Excellent communication skills written and verbal with a demonstrated ability to summarize and communicate findings in a timely efficient manner.
- Demonstrated ability to manage and prioritize multiple projects simultaneously and work with a sense of urgency.
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.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
