Director, CMC Dossier Management

at AbbVie in North Chicago, Illinois, United States

Job Description

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 – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Leads global regulatory dossier preparation activities by coordinating cross-functional 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. Implement well-defined, efficient processes for preparation, review and approval of these CMC sections. 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 to the CMC team. Influence development of new regulatory guidance, assure timely impact assessment, and implementation of new regulatory requirements. Will lead CMC Coordination activities for later stage and more complex projects, anticipate regulatory questions, and help drive first pass approvals

Responsibilities

+ 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 cross-functional 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 multiple projects of moderate 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.

+ Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of drug substance, drug product and analytical sections of CMC submission documentation. Develop and maintain submission document templates for CMC regulatory documents in collaboration with CMC Regulatory and Process R&D.

+ Partner with CMC Regulatory to assist CMC project teams in identifying submission-related risks and develop mitigation strategies. Provide local expertise in the use of e-Docs.

+ Develop an organizational memory of regulatory issues. Review regulatory guidance documents to develop and maintain expertise. 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.

+ Develop and maintain tools and templates to facilitate submission process. Lead cross-functional initiatives related to streamlining the regulatory submission dossier preparation processes.

+ Provide feedback to functional area management on performance of contributors. Capable of overseeing non-exempt personnel.

Qualifications

+ Bachelor’s Degree with at least 8-10 years of CMC functional experience required; Master’s Degree with at least 6-8 years of CMC functional experience preferred; PhD Degree with at least 4-6 years of CMC functional experience highly preferred.

+ Interdisciplinary experience required, some analytical and/or formulation experience strongly preferred.

+ 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 and efficient manner.

+ Demonstrated ability to make decisions based on scientific data, to manage and prioritize multiple projects simultaneously, and to work with a sense of urgency.

+ Demonstrated skills in negotiation, influencing others, and leadership.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?

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+ 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?

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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