Our client is a fast growing highly profitable multinational biopharmaceutical company with a rich exciting pipeline of drug compounds across a diverse range of therapeutic targets at an advanced stage in research. With a hugely experienced and successful executive management team this company has a newly created vacancy for an experienced Regulatory Affairs Associate Director.This newly created position will be located in Dublin with flexibility to work from home.
The Associate Director, Regulatory Affairs EU will report to the Head of Regulatory and will be responsible for the development and execution of innovative regulatory strategies for the company’s development projects, with a focus on Europe. The position will collaborate with internal cross functional teams to provide regulatory input into clinical programs and with CROs to ensure appropriate oversight and the timely submission, approval and compliance of CTA applications. This position will also require key contributions to department and company initiatives related to regulatory affairs operations and strategy.
Duties and Responsibilities
- Provide regulatory leadership on project teams and working collaboratively with the project teams to identify optimum regulatory strategies for assigned projects.
- Lead teams in examining regulatory strategy options and relevant regulatory guidance and precedent.
- Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks.
- Monitor and analyze appropriate regulatory agency activities in areas of interest to the company and assess potential impact on programs. Able to take a global view on regulatory strategy and help teams navigate different regional requirements and the interplay between key regulatory agencies.
- Interact with regulatory authorities, and outside consultants when needed.
- Oversee and manage external regulatory and development vendor resources.
- Prepare and lead a team through a regulatory meeting.
- Write, review and edit regulatory documentation, ensuring it is fit for purpose, and to serve as a resource for regulatory document authors regarding the appropriate content of submissions.
- Supervises and provides guidance to other regulatory personnel as assigned and supports their career development.
- Lead department initiatives and seek opportunities to improve interdepartmental collaboration.
- Build intra-team and interdepartmental relationships and collaborate effectively in a global team environment.
- Minimum Bachelor’s degree; studies in science and advanced degree desirable
- Minimum 8+ years progressive Regulatory Affairs experience
- Specialized knowledge that would be desirable and supportive of success in this position includes:
- Understanding of regulatory requirements for and hands on experience with submission of applications (e.g. INDs, NDAs, MAAs, CTAs)
- Extensive experience partnering with CROs on regulatory submission activities
- Experience working on development programs and driving regulatory strategies specifically relating to clinical and pre-clinical aspects of the project.
- Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
- Experience in other key functional areas, (e.g., toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics) appreciated
- Experience in pediatric and orphan drug development and understanding of EU regulations related to pediatric and orphan requirements
- Experience in label development and maintenance
- Demonstrated track record of success building relationships with, and influencing, EU regulatory agencies, particularly in situations requiring direct interaction/negotiation
- Experience working in a global team environment.
- Desired Personal Characteristics:
- Highly responsible, self-motivated individual professional
- Strong leadership skills that include a desire for accountability
- Highly collaborative working style with the ability to influence others
- Superior work ethic that includes working with an appropriate sense of urgency
- Entrepreneurial orientation with the ability to effectively operate in a dynamic environment
- Excellent organizational skills that enable the successful execution of multiple simultaneous projects.
Cv to firstname.lastname@example.org 01 2302400