Key Responsibilities
* Develop and implement robust regulatory strategies to support product development and lifecycle management, particularly for expanding portfolios.
* Lead and mentor a team of Regulatory Affairs Officers, fostering a collaborative and high-performing environment.
* Efficiently integrate all new portfolio acquisitions across multiple international markets.
* Spearhead projects to identify and resolve gaps in regulatory dossiers.
* Lead high-level meetings with Regulatory Authorities.
* Drive the regulatory aspects of internationalizing products and pursuing reclassification when appropriate.
* Proactively monitor and interpret global regulatory trends and changes, ensuring the company is always ahead of the curve.
Our Ideal Candidate
1. A resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs.
2. 8-10 years of progressive experience in Regulatory Affairs within the pharmaceutical industry (human health).
3. Strong knowledge of global regulatory frameworks, including MRP, DCP, and CP procedures.
4. Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries.
5. A proactive,