Who we are

At Roche, 82,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

The Position

The Drug Regulatory Affairs Manager (DRAM) is responsible for the management of the activities related to the registration of the products and the relations with the authorities.

The Drug Regulatory Affairs Manager prepare, adapts the registration file and registers the products with the local authorities in a timely and accurate way, in line with the company strategy and with the local regulations and maintains the products registration status in accordance with local legal requirements and Roche regulatory SOPs

Key responsibilities:

• submit files for registration, renewals and follow-up on their evolution,
• submit documentation for variations approval for already registered products,
• submit requests for any type of promotional material and follow-up for local legal approvals,
• submit documentation for CTA, amendments and follow-up for local legal approvals,
• Up-date continuously the company with information from Health Authorities.
• Enhance the Company image with Ministry of Health key contact persons and maintain close contact with the Key decision-makers in order to create goodwill for the company.
• Declare the products prices and follow – up for local legal approvals,
• obtain import certificate and other relevant documentation in accordance with local legal requirements,
• collect all requested documentation for the product and/or indications files proposed for reimbursement/compensation
• submit timely the complete documentation for the reimbursement/compensation proposals.
• Prepare all labeling texts for the products in accordance with local requirements and company SOPs in order to maintain the regulatory compliance of Roche products in close cooperation with global PDR (Pharma Development Regulatory) department,
• prepare regulatory submissions in collaboration with the Basel PDR product responsible employees,
• acquire and maintain an overview of relevant regulatory requirements,
• support and coordinate the submission of core CTA (Clinical Trial Applications) and amendments for clinical studies.
• Prepares and supervises the production of the packaging labels in the local language and support Qualified Person in his/her duties.
• Prepare and update SPC intended for promotional material.
• Ensures that all activities he/she is responsible for are carried out correctly, completely and timely

Continuously updates his/her knowledge level over the Company products.

Handles the Company assets with care and according to the Company policy. Ensures the safe custody and good maintenance of assigned Company property (car, computer, phone, product samples and literatures etc.)

Does not disclose any information or materials that belong to the Company and are for internal use

Makes decisions, within his/her competing limit, in his/her field of activity

Participates in seminars and courses to improve his/her knowledge and abilities

Continuously protects and enhances the Roche image in the market

Handles other job related responsibilities and tasks that are assigned by his/her superiors

Identifies, collects and immediately reports all safety-related information on Roche products to Drug Safety Unit.

Who you are

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in You want to work in a performance-oriented environment and demonstrate your leadership potential through entrepreneurial action. Mutual respect and the exchange of opinions with all levels of hierarchy are important to you.

• Pharmacist
• 3 years experience as DRA
• Fluent English
• Negotiation Skills,
• Good writing skills.
• Leadership in non-hierarchical situations
• Ability to build a dependable network across all major functions
• Appreciates the diversity of working across multiple cultures and countries
• Strong planning and project management skills
• Negotiation skills
• Persuasion and influencing skills
• Superior English verbal and written communication skills
• Ability to manage budgets
• Innovative & courageous attitude

The next step is yours. To apply today, click on the "Apply online" button below.

Roche is an Equal Opportunity Employer

Apply online