JOB INFORMATION:

JOB SUMMARY:

• Accountable for creating drug product submissions for BoH acceptability in terms of content, according to local regulations and requirements. This includes HA query responses.
• Ensure dossiers (Example: electronic, paper copy, and HA portal) are produced and dispatched to markets according to their defined filing plan and are submission ready.
• Ensure the processes transparency and excellence in execution of regulatory strategies.
• Maintain the accuracy of the data in the 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.

JOB RESPONSIBILITIES:

• Accountable for coordinating the submissions for post approval, NCE and biologics Drug Products by countries acceptability in terms of content, according to local regulations and requirements. This includes HA query management.
• Possess a thorough understanding and application of the Hub procedures.
• Understand local regulations and trends, as communicated by the PCO.
• Liaise with CMC, Submissions Management, Cluster/Market, and any other key stakeholders to ensure BoH requirements are met.
• Create submissions as per assigned responsibility, ensuring BoH requirements are met.
• Author local submission documents in relevant databases, as applicable.
• Execute regulatory strategy (including timelines) in alignment with the agreed upon strategy from key stakeholders (i.e., Global Regulatory Team, PGS, Markets, Clusters, Labeling team, Submissions Management, CMC) to ensure a submission ready dossier.
• Liaise with the manufacturing sites for obtaining supporting documents as needed
• Utilize a submission planning and forecasting tool to update timelines when necessary.
• Review submission packages against local BoH requirements for consistency and completeness.
• Update the appropriate regulatory requirements systems and database in a timely manner when changes occur in market regulations.
• Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention, as needed.
• Complete departmental training in a timely manner to address corporate and regulatory compliance.
• Drive improved efficiencies across the region through achieving consistency in submission strategies and its execution. Make suggestions and recommendations that contribute to improvements in the Hub.
• Maintain an active partnership with counterparts across the Hubs.

QUALIFICATIONS / SKILLS:

QUALIFICATIONS:

• Bachelor’s degree or equivalent i.e., degree in Chemistry, Pharmacy, or a related life science
• MSc, MBA or PhD may be an advantage
• Experience in regulatory affairs, preferably in human medicines - minimum 3 years
• Demonstrate regulatory experience with a pharmaceutical company.
• Proven ability to support complex regulatory issues and consistently deliver to time, cost and quality standards.
• Regional regulatory experience including knowledge of NCEs and biological products submission processes, CTAs applications (as applicable) and product life cycle management activities.
• Demonstrate experience of effective delivery in a complex matrix environment.

SKILLS:

• Knowledge of regional and global regulatory environment
• Technically competent to understand CMC submissions, interpret and communicate BoH requirements, and identify potential regulatory risks.
• Knowledge of drug development, regulations and guidelines
• Strong leadership qualities, including excellent 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 at all levels in the organization
• Team player
• Analytical thinking
• Talent development
• Change agile

EEO (Equal Employment Opportunity) & Employment Eligibility 

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.