Principal Regulatory Affairs Specialist
Lead regulatory strategy and submissions, ensure compliance and work with cross-functional teams in a senior capacity. Advanced regulations knowledge and 8+ years experience are required.
The Principal Regulatory Affairs Specialist position is a full-time senior opportunity in a reputable pharmaceutical environment. A competitive salary and comprehensive benefits are provided for the right professional, and the company seeks candidates with extensive regulatory knowledge and significant prior experience.
Role Overview & Key Responsibilities
This position involves leading all regulatory affairs strategies, preparing and submitting detailed dossiers, and navigating both national and international pharmaceutical regulations. The role requires close work with R&D and various departments to ensure compliance from development through product lifecycle, as well as managing audits, inspections and regulatory relationships. Individuals will also offer guidance internally on evolving global regulations and maintain up-to-date compliance documentation.
Преимущества данной должности
One attractive aspect is the chance to play a senior leadership role within an established company, influencing key compliance decisions. Professional growth is fostered through interaction with a skilled multi-disciplinary team, and your broad regulatory knowledge will make an immediate impact. Another plus is the structured and supportive working environment, known for stability and integrity.
Возможные недостатки
However, the seniority of the role demands long hours and a high degree of accountability. Applicants without international regulatory experience or those who lack advanced organisational skills may find the complexity challenging. Also, strict requirements regarding qualifications might limit some highly capable but less credentialed candidates.
Verdict: Is This Right for You?
This is a prime opportunity for a seasoned regulatory affairs specialist aiming to step into a leading role, shaping policy and driving compliance. If you have significant pharmaceutical regulatory experience—ideally including dossier submission and audit leadership—plus excellent communication abilities, this could be your next career move.
