Associate Director, Regulatory Operations

**Summary**

Management responsibility and daily operational oversight for the timely compilation of regulatory submissions to meet all regulatory requirements in support of key submission milestones. Facilitates processes and templates and provides leadership to functional contributors with regard to compliant submission deliverables in support of electronic submissions including eCTD. Responsible for the administration of the document management and regulatory information management systems, as well as the development and implementation of processes and requirements intended to standardize and streamline the submission process. Appropriately prepares and supports the Regulatory Liaison team for interactions with regulatory authorities.

**Duties and Responsibilities**
- Oversee regulatory operations, including submission publishing, RIM and document management.
- Create development and marketing authorisation submissions to global Health Authorities in paper, eCTD and other non-eCTD electronic formats as required.
- Facilitate implementation and maintenance of an eCTD publishing solution including management of resources.
- Negotiation, liaison and commitment tracking with eCTD contract provider for submission support, as needed.
- Provide training and support to relevant team members on the use of regulatory publishing/review systems and submission procedures and on the use of the EDMS in the creation of regulatory documents.
- Development, implementation and maintenance of department SOPs, policies and/or work processes to streamline all regulatory submission activities and standardise interactions with other departments.
- Remain knowledgeable and up-to-date with electronic submission requirements, including the testing and evaluation of new electronic software tools.
- Coordinate the preparation and review of documents for regulatory submissions (e.g. cover letters, forms, DSURs, safety reports).
- Participate in the preparation of dossiers containing manufacturing, preclinical, and clinical data.
- Provide guidance to authors for clear document and data presentation and location in order to optimise submission navigation as well as the regulatory review and approval process overall.
- Contribute positively to a strong culture of business integrity and ethics.
- Act within compliance and legal requirements as well as within company guidelines.

This position also supports regulatory liaison activities as follows:

- Partner with authors to ensure clear document and data presentation and location in order to optimise submission navigation as well as the regulatory review and approval process overall.
- Track and reports on regulatory milestones globally.
- Other responsibilities, as necessary.

**Requirements**:

- Bachelor or Master’s degree (in science, technology, health
- related field, or business management preferred) or equivalent experience.
- Minimum of six years’ experience in a regulatory affairs environment with document management systems, electronic publishing systems and electronic submissions, including eCTD, CTAs, direct submission to global Health Authorities.
- Minimum of three years’ experience in managing people.
- Extensive knowledge of CTD/eCTD from both regulatory and technical perspectives.
- Strong knowledge of EMA regulations, 21CFR Part 11, and ICH, FDA, EMA, and Swissmedic guidance.
- Thorough understanding of the drug development process EMA and Swissmedic requirements regarding regulatory submissions, electronic document management systems, and eCTD submissions. Knowledge of US and other health authority requirements is highly desirable.
- Experience with packaging and labelling, and combination products submissions preferred.
- Strong technical knowledge and working skills in publishing and related computer software including advanced MS Word, Adobe and Adobe plug-ins. Familiarity using Veeva Vault and Lorenz docuBridge preferable.
- Excellent communication and interpersonal skills with demonstrated leadership and flexibility in dealing with change and diversity.
- Excellent organization skills and ability to manage multiple priorities and projects.
- Strong commitment to quality and continuous improvement including attention to detail and quality.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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