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All vacanciesRegulatory Affairs Manager
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