Regulatory Sciences Manager

JOB SUMMARY

Summarize the primary purpose & key accountabilities of the job.
- Provide managerial oversight to the Regulatory Organization to execute regulatory strategies.
- Support the Head of Regulatory Sciences Mexico to achieve the regulatory authorizations in the Country, within the legal standards and established timelines.
- Coordination and implementation of consistent standards and processes.
- Compliance with Sanitary regulations and corporate policies.
- Actively participate in meetings with representatives of Regulatory Agency, other Regulatory Agencies, and Trade Associations. Coordinate activities related to dossier submission (paper and/or electronic) for Innovative drug products for country acceptability in terms of content, according to local regulations and requirements. This includes HA query management.
- Interact with key stakeholders, such as the LatAm Regional Hub to ensure the regulatory strategy has been executed in a timely manner.
- Familiarize themselves with the latest changes in BoH legislation, and communicate this to the LatAm Regional Hub, to ensure the necessary systems and databases are updated as necessary.
- Work in collaboration across the Cluster to deliver efficiencies in regulatory submissions and processes.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.
- Perform managerial oversight to assure approvals for New Products, Line extensions, Variations, Renewals on time and based on the strategy established following the legislation and corporate policies.
- Support the development strong partnerships with in-country teams (e.g. Country Managers, Medical, Marketing, Supply Chain), Regulatory Clusters, Regulatory Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and lifecycle optimization.
- Provide strategic contribution to anticipate what Regulatory needs to contribute to achieve business objectives.
- Manage the BoH technical meetings through the lifecycle of a product, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance and Leadership.
- Understand local regulations and trends in the local regulatory environment and provide assessment of the impact to key stakeholders.
- Possess a thorough understanding of the market requirements, as well as the regulatory processes.
- Coordinate the activities related to submissions.
- Work closely with the LatAm Regional Hub to ensure submissions are ready to file, and provide the necessary information to ensure internal systems and databases are updated.
- Coordinate the routine monitoring of Agency’s website for information related to product registration, line extensions and post-approval changes. Understand local regulations and trends.
- Ensure the Team keeps current with the BoH legislation, as well as updates the regulatory information on Pfizer’s systems and/or sharepoints.
- Coordinate the review of submission ready dossiers, ensuring that submissions fully meet the local regulatory requirements. This includes BoH query response.
- Work in partnership with the LatAm Regional Hub.
- Propose and/or develop improvements to the regulatory processes.
- Participation in internal audits.
- Coordinate the preparation of the registration license renewal for products. Participate in meetings with Agency, Trade Associations and other Agencies related to drug registration.
- Support tender processes by providing updated regulatory documents.
- Complete departmental training in a timely manner to address corporate and regulatory needs.
- As applicable, contribute to local regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.

QUALIFICATIONS / SKILLS

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

Qualifications:

- Scientific Degree. A higher degree (MS or PhD) may be an advantage but is not essential. Pharmacist degree may be mandatory in some countries.
- Appropriate Regulatory Experience - minimum - 5 years experience.
- Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
- Proven ability to manage complex regulatory issues.
- Proven ability to consistently deliver to time, cost and quality standards.
- Local regulatory experience including knowledge NDA submission processes for high speciality products (small molecules, orphan drugs, vaccines, biological products) and product life cycle management activities.
- Demonstrable experience of effective delivery in a complex matrix environment.

Skill Requirements:

- Knowledge of the Local regulatory environment and how this impacts regulatory strategy and imple