Regional Regulatory Hub Strategist (W190)

Pfizer

  • Suba, Bogotá DC
  • Permanente
  • Tiempo completo
  • Hace 17 horas
Why Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.**Responsibilities**:- Accountable for coordinating the submissions for post appoval, NCE and biologics Drug Products by countries acceptability in terms of content, according to local regulations and requirements. This includes HA query management.
- 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**:
Must-Have
- 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.
- Demonstrate experience of effective delivery in a complex matrix environment.- Bilingual (Spanish/English)Nice to Have
- 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 AgileWork Location Assignment: FlexiblePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs

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