- 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.
- 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
If you feel that you can meet the qualification and up to the challenge, please send your complete application (application letter, resume, expected salary and any related supporting documents) and current color photograph at size 4 x 6 cm by clicking button bellow
Review ( PFIZER INDONESIA, PT )
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- Senior Manajemen
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adanya suasana kerja yang kondusif, rekan kerja yang saling mendukung dan saling membantu dan fasilitas yang disediakan juga sangat memadai.
seringnya jam kerja lembur yang dilakukan, sistem administrasi yang kurang baik sehingga menyulitkan karyawan dan sering adanya meeting yang mendadak.