REGULATORY COORDINATOR

For more than 125 years STADA is taking care of a great good: your health. The care for health and well-being of people is the center of STADA's trade. The company's philosophy and mission statement are based on this central purpose.

Job Description
The scope of duties includes all necessary activities to provide new and update Technical Files according to the Medicine and Medical Device Regulations.

 Your main tasks:

• Responsible for all activities of preparation of pharmaceutical files for the company's products in order to (re)authorize the documentation, as well as for pharmacovigilance, specialized training, scientific presentations about products for doctors and pharmacists
• Preparation of documentation for all company portfolio products for customer-specific requests (tender, etc.) in co-operation with Global Regulatory Affairs so that it would be in accordance with the regulations of the Romanian authorities and of the European institutions
• Identifies and signals in due time the legislative changes in the field of pharmaceutical and para-pharmaceutical products
• Knows the Rules of Good Manufacturing Practice of medicines;
• Advises collaborators and producers on legal requirements;
• Evaluate the impact of changes on local current & ongoing registrations on business level
• Develops and implement specific working procedures within the Regulatory Affairs Department, according to the legislation in force
• Maintains the relationship with the health authorities (Ministry of Health, ANMDM)
• Monitors and sets deadlines for obtaining product’s notifications
• Drafts clear arguments and explanations for notifying new products as well as for re-approving products in the portfolio
• Maintain strong relationship with the respective department on STADA Group level and adjust the status of the re / notified products, prepare periodic necessary reports
• Keep clear records for notified products
• Collects and classifies product information
• He/she is constantly  up to date with the STADA product portfolio, contributing to (re)launches of products or portfolio development plan;
• Carries out specialized training for STADA employees and collaborators
• Produces material with medical content for various needs of the company (labels, promotional materials, magazines, product catalogs, etc.) in collaboration with the Marketing and Sales departments
• Participates in the creation, maintenance and improvement of the company's image and the company's products, both in front of customers and collaborators, as well as competitors on the market

• Manages with maximum efficiency the new registrations/renewals / extensions/variations of the assigned line, submission, and approval, in accordance with the company's strategy and with the regulations in Romania.
• Provides support to other departments in terms of the launch plan, implementation of changes in the market, discontinuation of products sold.
• Notify the supplements marketed by STADA M&D SRL to the Institute of Food Bioresources (IBA)
• Responsible for the pharmacovigilance activity on the Romanian territory, for the products in the portfolio, in the absence of the Local Pharmacovigilance Officer (OLF).
• Assure high-quality external communications for health professionals, truthful and accurate, in accordance with applicable EU and local laws, NAMMD regulations and guidelines, Min. Health.

Your profile:

• University degree (pharmacy, medical engineering, chemistry, biochemistry, biology or medicine)
• Experience in preparing medicine and medical devices documentation and regulatory affairs field
• Broad understanding of the pharmaceutical market;
• An analytical and structured way of thinking and working
• Organized with good communication skills,
• Teamwork skills
• Advanced computer literacy;
• Willingness to travel;
• Fluent in English: written and spoken;

The company will offer you:

• Opportunity to be part of a corporate culture that dedicated to the main purpose: carrying for people’s health
•  Opportunity to become part of an enthusiastic team in a fast-growing company
• You will have the right place to demonstrate your excellent expertise, skills, and needed abilities for this role