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Growth Lead


Cairo, IL 62914
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Job Details

**Position Purpose**

Accountable for creating the new to market submissions for PEH Drug Products for country acceptability in terms of content, according to local regulations and requirements. This includes BoH query management before to obtain of register of the product..

Ensure dossiers (Example: electronic, paper copy, and BoH portal) are produced and dispatched to markets according to their defined filing plan, and are submission ready.

Ensures the processes transparency and excellence in execution of regulatory strategies.

Maintain systems and databases per internal SOPs and policies.

Work in collaboration across the organization with stakeholders (such as Product Strategist, Commercial, Operations) to deliver efficiencies in Regulatory submissions and processes.

Work in collaboration with Business Development teams in the region for new business case evaluation, including conducting due diligence on acquisition, joint venture, contracted services or in-license opportunities.

**Primary Responsibilities**

+ Manage new to market submissions.

+ 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.

+ Function as the Lead on new submission regulatory requirements, and liaise with CMC Product Lead/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 CMC 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

+ Lead/supervise regulatory strategists (colleague and/or external vendors). Guide and support the Hub Team to achieve agreed objectives.

+ Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.

+ Ensure internal regulatory processes and procedures are well documented.

+ Ensure Departmental training to address corporate and regulatory needs.

+ 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.

+ Lead due diligence on new business opportunities across the region. Apply regional and market knowledge to ensure strategic and factual evaluation of opportunities.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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