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Job Description
PURPOSE OF JOB/POSITION
The Regulatory Affairs Head manages the process for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general products life cycle management including pro-brand strategies.
Also, is responsible for develop submission strategies; provide guidance/advice on local country regulatory environments; provide assessment of the impact of new and changing regulations/requirements. Keep strong relationship with key external stakeholders such as BoH and industry associations.
ACCOUNTABILITIES
- Evaluate local business and regulatory registration requirements for investigational and marketed products, prepare regulatory assessment reports.
- Develop submission strategies; prepare project plans, timeslines and related project fees. Prepare project status reports for management/departments.
- Prepare and submit investigational applications, market applications, varations, post approval reporting obligations and general product life cycle management support.
- Provide strategies to management and interact with regulatory agencies to resolve related agency review questions.
- Maintain a centralized archive of all regulatory files.
- Establish a library of all applicable regulations and guidance documents
- Provide guidance/advice on international regulatory environments; provide assessment of the impact of new and changing regulations/requirements.
- Participate and provide international guidance to CMC, preclinical, clinical and marketing program teams as needed.
- Develop strong and effective working relationship with regulatory agencies and company consultants and partners.
- Develop meeting materials and chair/attend meetings with regulatory agency inspections.
- Review promotion and advertising materials.
- Proactively participate in all the activities defined according to the position and role, within the framework of the SG-SST Occupational Health and Safety Management System.
Experience & Education:
- Bachelor´s degree, preferably in chemistry and/or pharmacy.
- Minimum 7 years of experience with multinational companies in Regulatory Affairs
- Minimum 5 years managing a team and as part of leadership team.
- Proven experience managing regulatory authority INVIMA.
- Desirable experience in managing consult-ants and authorities in Andean Countries.
- Fluent verbal and written communication skills in Spanish and English.
Competences & Skills:
- Solid people management skills and a desire to develop team members.
- Proven ability to motivate diverse teams to achieve high standards and deliver results according to our objectives.
- Excellent downwards and upwards internal and external communication skills.
- Committed to foster a diversity, equity, and inclusive environment.
Locations
Bogota, Colombia
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
