2 months ago
The Director will serve as the Global Regulatory Lead with the Global Development Team/s and will provide strategic regulatory guidance for assigned programs in the inflammation therapeutic area. The GRL will represent regulatory affairs at cross-functional team meetings and will serve as the primary contact with the FDA for the assigned project(s).Job Responsibilities:
- Represents GRA and serves as a Core member of the cross functional Project Team and provides overall regulatory input for the project(s) globally
- The GRL will work transversally to ensure a properly functional regulatory project team. The GRL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries. The GRL will ensure the development of robust global regulatory strategies for development program
- The GRL is accountable to present the global regulatory strategy/position to senior management / governance committees as needed.
- Has demonstrated ability to act as primary Company contact with Regulatory Authorities. May have experience working with Regulatory Authorities in multiple territories.
- Responsible for leading all regulatory activities for assigned project(s) and territories, in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Responsible for preparing and/or overseeing the preparation of technically complex regulatory affairs which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products, in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include briefing documents, supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories.
- Develop pediatric regulatory strategies and contribute to preparation of investigation plans for HA submissions, i.e. PIP/PSP
- Oversees preparation and maintenance of country specific labeling and product packaging (region specific)
- Ensures up-to-date knowledge of highly complex regulatory requirements, contributes to preparation of new regulatory guidances, comments on draft regulatory guidances, and communicates changes in regulatory information to project teams and senior management.
- Initiates local process improvements and contributes to local and / or global process improvements, SOP updates, which have a significant impact for the Regulatory Affairs Department or other departments.
- Excellent verbal and written communication, negotiation and interpersonal skills.
- Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
- Work is performed under consultative direction towards corporate regulatory goals and objectives.
- Schedules and arranges own activities and those of direct report(s) (if applicable).
- Previous people management experience is preferred.
- Is recognized as an expert resource for Regulatory Advice in other departments
Education & Experience:
- Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
- Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
- 12+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
- 10+ years of experience in Regulatory Affairs or other relevant industry experience with advanced degree
- Degree in a scientific field is preferred