Job opportunities

Job description

We are currently looking for a RA Manager. The successful candidate will be responsible for execution of regulatory applications of various types of pharmaceutical applications.

JOB DESCRIPTION

As RA Manager, you will:

•  Provide regulatory operations support in a start-up environment
•  Manage regulatory submissions across different stages of the development path
•  Manage and publish medicinal product dossiers
•  Collaborate with vendors to submit applications and reports to applicable regulatory

agencies within established timelines and high-quality standards

•  Keep track of regulatory procedures and organize responses to information requests and

commitments given to health authorities

•  Manage and publish medicinal product dossiers
• Focus on development of reformulated or repurposed value-added medicines in a broad

variety of therapeutic areas

•  Participate in technical discussions, project meetings and reviews
•  Collaborate with the company’s multidisciplinary team and outside partners
•  Publish and author submission packages (including, but not limited to, Scientific Advice, CTA, MAA)

YOUR PROFESSIONAL PROFILE

• Minimum Qualification: Master medical, pharmaceutical or life sciences
•  Minimum Experience: 3+ years industrial experience in regulatory affairs
•  Languages: English (written and verbal) – French is an asset
•  Computer proficiency is mandatory
• Experience with European & FDA regulations & guidelines on drug development is required
•  Direct experience with publishing of submission packages is required
•  Familiarity with GMP, GLP, GCP, and ICH guidelines is required
•  Experience with regulatory submissions software an asset

YOUR ABILITIES

• Demonstrates strong work ethics, and effective written and verbal communication skills
• Strong problem-solving skills with an aptitude for providing solutions
• Ability to balance a sense of urgency with adherence to quality
• Excellent written and verbal communication
• Meticulous attention to detail regarding publishing of submission packages
• Be proactive and results-oriented with a focus on business needs
• Strong interpersonal skills, a collaborative and trust enabling working style, building
• partnerships among key stakeholders
• Organizational aptitude to be a part of an outstanding team
• Adaptability, flexibility, independence, and resourcefulness to both lead a big vision strategy
• while also being willing to roll-up-sleeves and multi-task to thrive in a start-up environment
• dedicated to growth
• To have essential professional attributes include analytical thinking, team-player attitude,
• mutual respect and understanding for cultural differences in a global team and environment and efficient utilization of time and resources