Regulatory Affairs Manager (New Created Position)
Regulatory Affairs Manager (New Created Position)
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
PRIMARY OBJECTIVE:
- To manage the preparation of regulatory submissions of company products in order to obtain necessary regulatory approvals
- To provide regulatory input on regulatory matters to company personnel.
- This position will report to the RA Director with people management scope.
CORE JOB RESPONSIBILITIES:
- Develop registration strategies and implement regulatory plan in accordance with strategic company objectives.
- Manage registration of new/line extension products variations to marketed products to ensure regulatory approvals are achieved in accordance with Company objectives.
- Oversee regulatory affairs activities within the team including regulatory submissions approvals and compliance.
- Manage safety update reports certified product details and import permits
- Maintain contact with governmental officials of Korea MFDS to facilitate evaluation processes.
- Liaise with operations department and others to maintain product changes and ensure these comply with regulations.
- Review and assess product labeling packaging and promotional materials for compliance with relevant regulations and codes.
- Collaborating with cross-functional teams to identify and address regulatory compliance gaps and develop corrective actions.
- Analyzing and interpreting complex regulatory requirements and guidelines to determine their applicability to the organizations products and operations.
- Proactively identifying potential regulatory risks and proposing mitigation strategies to ensure compliance and minimize business impact.
- Provide support for marketing plans and launch teams
- Maintain good knowledge of the relevant Regulations & Code.
- Bridge for translating regulatory strategies and goals into launch plans that drive the business
- Manage performance of their Therapeutic Area
- Coach and develop team members to achieve their best target
- Shape the culture of the team
- Serve as a Back-up to the RA Director: Act as the deputy and take on the responsibilities of the RA Director in their absence.
Qualifications :
EDUCATION/QUALIFICATIONS/EXPERIENCE:
- University degree in appropriate discipline
- More than 10 year experience in a regulatory position in the pharma industry with proven track records in driving new drug project
- Experience in Neurology will be preferred
- Experience in people management is a great plus
- Must be proficient in both spoken and written English.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
