For our location in Ludwigshafen, Germany we are looking for a
Associate Director CMC Dossier Management (m/f/d)
Leads global regulatory CMC dossier preparation activities for biologics as well as small molecule drug substance, drug product, analytical and device sections. Manages cross-functional matrix teams of subject matter experts, from internal and external third parties that author CMC common technical documents (CTD). The primary function is to ensure consistent preparation of CTD of high scientific and technical quality that are compliant with global regulatory requirements. Implement well-defined, efficient processes for preparation, review and approval of CMC sections and develop new processes utilizing structured content authoring and automated data transfer into CTDs. Primary location of the position will be Ludwigshafen, Germany or alternatively North Chicago, United States.
- Author and coordinate submission documentation preparation for all phases of clinical development, often under significant time pressure. Proactively author responses and drive team resolution activities to questions from regulatory authorities during submission and agency review process, respectively.
- Leverage extensive biologics and small molecule drug development experience to lead the global cross-functional CMC Team in authoring and management of global regulatory submission documents during standard clinical development like IND, IMPD, briefing books for type A, B, and C meetings.
- Demonstrate excellent interpersonal skills and strong negotiating, influencing, and leadership skills.
- Interface with CMC Regulatory personnel to ensure consistency across projects. Represent the CMC team in communication of issues to management.
- Develop and maintain tools and templates to facilitate and improve submission processes. Lead cross-functional initiatives related to streamlining the regulatory submission dossier preparation processes with a focus on utilizing structured content authoring and automated data transfer into CTDs.
- 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, significant analytical and/or formulation experience strongly preferred.
- Experience in structured content authoring and/or automated data handling for compilation of regulatory dossiers is 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.
- A fantastic opportunity to work in in a world-class team.
- A mentor who will assist you as coach and contact person.
- A supportive environment that allows you to focus on your role and tailor your work to your individual needs, including flexible work models, multiple benefits, and comprehensive health and sports programs.
- Attractive compensation and company benefits, including our excellent occupational health management system, which is one of the best in Germany.
Contact: Alexander Krüger (email@example.com)
We are looking forward to your online application.
Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re active.