Purpose
We are seeking a Regional Regulatory Scientist to provide expertise in supporting high‑quality and efficient regulatory submissions, approvals, and local labelling for assigned products. This role will play a key part in ensuring compliance with regional requirements and supporting interactions with regulators.
Key Responsibilities
* Provide input and review of global strategic and submission plans for assigned products.
* Support regional regulatory leads in governance committees and regulator meetings.
* Ensure timely approval and delivery of local regulatory submissions, engaging cross‑functional partners.
* Contribute to the development of local/regional labelling strategies, applying competitor knowledge and regulatory precedent.
* Maintain compliance with applicable regulations and internal quality systems.
* Interpret new guidelines and anticipate their impact, initiating change where needed.
* Own regulatory activities for marketed products in the assigned region.
* For US support: contribute to promotional claims development and advise on promotional strategy.
* For EMEA support: ensure registration needs for local patients in clinical trials are met.
Leadership & Collaboration
* Partner with global regulatory leads to resolve development and registration issues.
* Liaise with affiliates to anticipate region‑specific challenges, including labelling impacts on promotion, pricing, and reimbursement.
* Participate in regional and cross‑functional meetings to align regulatory strategies.
* Drive continuous improvement projects to simplify processes and increase productivity.
* Represent regulatory functions on cross‑functional initiatives.
* Foster an inclusive environment that encourages open discussion and robust decision‑making.
Qualifications
* Bachelor’s degree in a scientific or health sciences discipline.
* 1–3 years of industry or relevant experience.
* Strong knowledge of local/regional regulatory procedures and drug development processes.
* Solid communication skills (written, spoken, presentation).
* Ability to work independently with attention to detail.
* Developing negotiation and influence skills.
* Strong analytical skills and ability to manage risk in a regulated environment.
* Advanced teamwork skills, embracing diversity, equity, and inclusion.
Additional Information
* Key contacts include project team members, global regulatory leads, regional marketing/medical, and affiliate representatives.
Please apply on Linkedin.