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Growth Strategist


Berkeley Springs, WV 25411
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Job Details

**Position Purpose**

+ Accountable for creating the submissions for products for country acceptability in terms of content, according to local regulations and requirements. This includes HA query management.

+ 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.

+ 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

**Primary Responsibilities**

+ To develop and execute regional regulatory strategies to support the registration of the portfolio.

+ Execute registration strategy (including timelines) in alignment with the agreed upon regulatory strategy from key stakeholders (i.e. PGS, Markets, Clusters, Labeling team, Submissions Management, CMC) to ensure a submission ready dossier.

+ Support all registration regulatory requirements, and liaise with CMC, Submissions Management, Cluster/Market, and any other key stakeholders. Update the appropriate regulatory requirements systems and database in a timely manner when changes occur in market regulations.

+ Utilize a submission planning and forecasting tool to update timelines when necessary.

+ Author local submission documents in relevant databases.

+ Review submission packages against local CMC requirements for consistency and completeness.

+ Liaise with the manufacturing sites for obtaining supporting documents as needed

+ Have a thorough understanding and application of the regional procedures

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

+ Complete departmental training to address corporate and regulatory needs.

+ Drive improved efficiencies across the region through achieving consistency in license application strategies and its execution.

+ Understand local regulations and trends, as communicated by the PCO.

+ Ensure appropriate due diligence for products brought into Pfizer, alliance partnerships or outsourcing of products.

**Technical Skill Requirements**

+ Knowledge of Regional and Global Regulatory environment.

+ Technically competent to understand, interpret and communicate requirements, and identify potential risks for products.

+ Knowledge of drug development, regulations and guidelines.

+ Leadership and management qualities, including excellent communication, negotiation, and interpersonal skills.

+ Understanding of biopharmaceutical industry, clinical trials and pharmacovigilance.

+ Knowledge and understanding of quality systems, processes, audit and inspection

+ Team player

+ Analytical thinking

+ Talent development

+ Change agile

**Qualifications (i.e., preferred education, experience, attributes)**

+ Bachelor's degree or equivalent i.e. degree in Biotechnology, Chemistry, Pharmacy, or a related life sciences.

+ MSc, MBA or PhD may be an advantage

+ Demonstrate regulatory experience with proven examples of contribution.

+ 1-3 years' experience in regulatory affairs, preferably in human medicines, Proven ability to support complex Regulatory issues and consistently deliver to time, cost and quality standards.

+ Regional Regulatory Experience including knowledge of BLA, CTAs, NDA, sNDA, ANDA, MAA submission processes.

+ Demonstrate experience of effective delivery in a complex matrix environment.

+ Bilingual: Spanish and English.

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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