GE HealthCare Pharmaceutical Regulatory Affairs Specialist 

Spain, Community of Madrid, Madrid 

378291427

Provides regulatory strategy and direction to the business regarding pharma industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations.Roles and Responsibilities

• Stay up to date on applicable local andhuman medicinesinternational regulations according to the position.

• Participation in international/European projects with a focus on globalization, improvement and simplification of medicinesregulatory issues.

• Compilation of required information for the registration dossier (MRP, DCP, CP, National), review and manage submission of variations ofhuman medicines,with the optimal preparation of documentation in accordance with the company's internal processes.

• Review and approval of the packaging material, promotional and advertising materialforhuman medicines.

• Participation and execution of work related to the request for price and reimbursement.

• Applying the company’s Standard Operating Procedures (SOPs) for regulatory.

• Maintain compliance and regulatory databases and organizing regulatory information and tracking.

Required Qualifications

• Bachelor's degree in subjects related to health sciences.

• Master's Degree in Regulatory and Pharmaceutical Affairs Preferred

• High level of written and spoken English

• Knowledge of current Spanish and European legislation on human medicines.

• Knowledge and Background inRegulatory proceduresatNational &European Level.

• Knowledge of websites and applicationsof theHealth Authorities, such as RAEFAR, Fraccionamiento, GESFARMA, etc.

• Knowledge of CTD format, VeeVa

Inclusion and Diversity:

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards:

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.