Thee Regulatory Associate will lead, manage the regulatory activities and provide support to the Country based PCO teams and above country regulatory teams to develop and execute regulatory strategies and plans for the country. Technical Skill Requirements - Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation - Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment. Experience in preparing and submitting CTA’s, NDA’s, variations and LC submissions. Working with and influencing opinion leaders, external organizations and PCO’s facilitating approval of submissions. Is driven to continually enhance regulatory expertise, both locally and globally. - Knowledge of drug development practice, rules, regulations and guidelines Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to Regional regulatory strategies and implementation plans. Maintains internal and external networks to learn in advance about new regulatory trends or changes impacting the Regulatory, Medical and overall Business strategy. - Strategic Thinker Provides strategic contribution and anticipates what RA needs to contribute to develop and achieve business objectives. Effectively explores alternative regulatory strategies and positions to reach outcomes that gain the support and acceptance of all parties. - Communication skills Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message. - Negotiation skills Can negotiate skillfully in tough situations with both internal and external groups depending on their seniority. Gains trust quickly of other parties to the negotiations. It has built a strong relationship with the local health agency and other relevant stakeholders (KOL’s) and proactively manages issues with the HA’s and other key external stakeholders. - Problem Solving Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed upon solutions. - Project Management Can manage complex and multiple projects Educational:• Pharmacy Degree.• Appropriate Regulatory Experience - Regulatory Affairs Associate, minimum of 1-2 yearsExperience:• Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.• Proven ability to manage complex regulatory issues.• Proven ability to consistently deliver to time, cost and quality standards.
Secteur d'activité:
Industries
Type de poste:
CDD Ou Mission
Niveau d'études:
Master 2, Ingéniorat, Bac + 5
Années d'experience:
Débutant / Junior
Catégories:
Santé, Médical, Pharmacie
Publiée le:
26-07-2025 à 15:35:38
