Senior Regulatory Affairs Manager
hace 3 semanas
Artixio is a global regulatory and quality services company with offices in USA, Germany, UAE, India and affiliates in about 70 countries.
As next leap of our growth, we plan to expand our presence in Mexico. We are inviting Regulatory Affairs Leaders to join our regional team. We are seeking entrepreneurial professionals who wish to be part of the business.
This role is combination of fixed salary and profit sharing as a local partner.
- 10+ years of regulatory experience within pharmaceutical and medical devices industry required
- Leadership experience
- Ability to work effectively in multinational/multicultural environment
- Sound basis of scientific (Training/ Communications) knowledge
- Ability to coordinate multiple projects in a matrix team environment
- Excellent oral and written communication and presentation skills
- Demonstrated excellent interpersonal and teamwork skills, including diplomacy to negotiate conflicting priorities
- Ability to lead, coach, and empower others
- Ability to accomplish results through others
**Responsibilities**:
The Senior Manager, Regulatory Affairs is responsible for defining regional regulatory strategies and submissions in Mexico in support of new and existing marketing authorizations (BLA, NDA, ANDA, MAA, NDS) for parenteral products (biologics, drugs), Medical Devices, Cosmetics and Supplements
Provide technical and strategic feedback for regulatory decisions aligned with business strategy
Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with internal and external standards
Assess impact of new regulations and provide feedback
Evaluate technical and scientific information, identify Chemistry, Manufacturing, and Controls (CMC) deficiencies, implement and execute strategies to remediate risks
Maintain appropriate communication within the RA function, and with Senior Leadership
Plan and manage sophisticated projects and prioritize workload
Initiate, manage and maintain operational activities in support of Clients' new and existing marketing authorizations (BLA, NDA, ANDA, MAA, NDS) and drug master files (DMF)
Support Global Business Team in preparing proposals/quotations for Services offered in Mexico
Participate in Client meetings and act as Mexico Regulatory Expert
Set team, group, or service objectives to assure they align with the regulatory strategy
Provide direct supervision of individuals including mentoring, performance management and staffing decisions
**Job Types**: Full-time, Contract
Contract length: 12 months
**Salary**: $30,000.00 - $60,000.00 per month
Application Deadline: 16/12/2023
Expected Start Date: 01/12/2023
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