Berakhir
28 Sep 09.00 ~ 2016.10.28 24:00
Dipublikasi 04 Oktober 2016
Lowongan Kerja Regulatory Manager
Simpan
Tersimpan
Batal
Tertutup
Company Introduction
Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.
Primary Responsibility
Responsibilities:
Manage new to market submissions for assigned products
Develops submission and approval strategy (including timelines) and execution in alignment and partnering with key stakeholders (i.e. PGS, Markets, Clusters, Labeling team, Submissions Management, CMC) to ensure a submission ready dossier.
Liaise with Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations.
Ensure a submission planning and forecasting tool is utilized to update timelines when necessary, communicate changes to relevant partners.
Capable of authoring local submission documents in relevant databases
Ensure submission packages are reviewed against local requirements for consistency and completeness
Liaise with the manufacturing sites for obtaining supporting documents as needed
Ensure thorough understanding and application of the Hub procedures
Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
Assist in ensuring internal regulatory processes and procedures are well documented.
Assist Regional RA leads drive improved efficiencies across the region through achieving consistency in post approval strategies and its execution.
Understand local regulations and trends, as communicated by the PCO.
Maintain an active partnership with the Regional Lifecycle Hub so they ensure post approval commitments are met.
Manage new to market submissions for assigned products
Develops submission and approval strategy (including timelines) and execution in alignment and partnering with key stakeholders (i.e. PGS, Markets, Clusters, Labeling team, Submissions Management, CMC) to ensure a submission ready dossier.
Liaise with Product Strategists. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations.
Ensure a submission planning and forecasting tool is utilized to update timelines when necessary, communicate changes to relevant partners.
Capable of authoring local submission documents in relevant databases
Ensure submission packages are reviewed against local requirements for consistency and completeness
Liaise with the manufacturing sites for obtaining supporting documents as needed
Ensure thorough understanding and application of the Hub procedures
Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
Assist in ensuring internal regulatory processes and procedures are well documented.
Assist Regional RA leads drive improved efficiencies across the region through achieving consistency in post approval strategies and its execution.
Understand local regulations and trends, as communicated by the PCO.
Maintain an active partnership with the Regional Lifecycle Hub so they ensure post approval commitments are met.
Qualification
Qualification
Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
MSc, MBA or PhD may be an advantage
Experience in regulatory affairs, preferably in human medicines - minimum 5 years of experience.
Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.
Regional Regulatory experience including knowledge of ANDA, MAA submission processes and Product lifecycle management processes.
Demonstrate experience of effective delivery in a matrix environment.
Knowledge of Regional Regulatory environment
Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
Knowledge of drug development, regulations and guidelines
Leadership and management qualities, including good communication, negotiation, and interpersonal skills
Understanding of pharmaceutical industry, clinical trials and pharmacovigilance
Knowledge and understanding of quality systems, processes, audit and inspection
Ability to influence peers in the organization
Team player
Analytical thinking
Change agile
Informasi lebih lanjut
| Bidang Pekerjaan | Status Kepegawaian |
| Quality Control | Full-Time |
| Pendidikan Terakhir | Gaji |
| - | - |
| Tingkat Jabatan | |
| - | - |
Powered By
