Job Seeker
Regulatory Affairs Manager
CATEGORY
Legal
TITLE
Legal Affairs
LOCATION
Cairo,
Egypt
EXPERIENCE
10-15
TYPE
SALARY
Negotiable
PUBLISH DATE
01 Dec, 2020
(5 years ago)
A reputable company located in 5th Settlement is hiring a Regulatory Affairs Manager
RESPONSIBILITIES
Job Description:
- Set submission strategy & Leading functionally the regulatory affairs departments in the region.
- Lead the preparation of regulatory documents/files required for new registration and Re-registration product maintenance (line extensions, variations, license renewals) and responses to Health Authority queries.
- Ensure that all the above RA documents/files are complied with the most recent regulations and being provided to distributor and or Health authority in challenging time frame to meet local RA plans/objectives.
- Keep up-to-date knowledge on regulatory legislation and requirements.
- Develop, write and update, as appropriate, RA document that encompasses all regulatory requirements/ legislations in countries to act as guidance and road map for management. With shared accountability and cross-functional teamwork together provide expert opinion to management in regards to new product development, portfolio management, and product approval.
- Set submission strategy & Leading functionally the regulatory affairs departments in the region.
- Lead the preparation of regulatory documents/files required for new registration and Re-registration product maintenance (line extensions, variations, license renewals) and responses to Health Authority queries.
- Ensure that all the above RA documents/files are complied with the most recent regulations and being provided to distributor and or Health authority in challenging time frame to meet local RA plans/objectives.
- Keep up-to-date knowledge on regulatory legislation and requirements.
- Develop, write and update, as appropriate, RA document that encompasses all regulatory requirements/ legislations in countries to act as guidance and road map for management. With shared accountability and cross-functional teamwork together provide expert opinion to management in regards to new product development, portfolio management, and product approval.
- Set submission strategy & Leading functionally the regulatory affairs departments in the region.
- Lead the preparation of regulatory documents/files required for new registration and Re-registration product maintenance (line extensions, variations, license renewals) and responses to Health Authority queries.
- Ensure that all the above RA documents/files are complied with the most recent regulations and being provided to distributor and or Health authority in challenging time frame to meet local RA plans/objectives.
- Keep up-to-date knowledge on regulatory legislation and requirements.
- Develop, write and update, as appropriate, RA document that encompasses all regulatory requirements/ legislations in countries to act as guidance and road map for management. With shared accountability and cross-functional teamwork together provide expert opinion to management in regards to new product development, portfolio management, and product approval.
- Bachelor degree of Pharmaceutical science.
- 10 + years of experience in RA management.
- Communication & Negotiation skills.
- Leadership & Management skills.
- Problem Solving & decision -making skills.
- Analytical Thinking.
- Result- oriented.