Job summary

• 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 region to deliver efficiencies in regulatory submissions and processes.
• Accountable for the Labeling and Non-Labeling submissions execution ensuring country acceptability in terms of content and alignment to local regulations and requirements. This includes BoH query management.
• Ensures the processes transparency and excellence in execution of regulatory strategies.
• Work in collaboration across the organization with stakeholders (such as Product Strategist, Commercial, Operations) to deliver efficiencies in Regulatory submissions and processes.
• Participation with Manager or Sr. Manager to provide suggestions or comments in the documents worked by Trade Association.

If Apply (Labeling):

• Apply knowledge and interpretation of regulatory requirements in the assigned countries related to labeling and artwork processes.
• 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.
• Guarantee systems and databases are timely updated per internal SOPs and policies.

If Apply (Promotional Materials):

• Accountable for the promotional material submissions execution ensuring country acceptability in terms of content and alignment to local regulations and requirements. This includes BoH query management.
• Apply knowledge and interpretation of regulatory requirements related to review of promotional materials.
• Ensure package for submission according the regulation, and submission ready.
• Ensures the processes transparency and excellence in execution of regulatory strategies.
• Update systems and databases are timely updated per internal SOPs and policies.
• Work in collaboration across the organization with stakeholders (such as Commercial, Operations) to deliver efficiencies in Regulatory submissions and processes.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

• Possess a through understanding of the market requirements, as well as the regulatory processes.
• Coordinate the activities related to submissions of Innovative drug products.
• 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 intranet.
• Coordinate the review of submission ready dossiers, ensuring that submissions fully meet the local regulatory requirements. This includes BoH query response.
• Coordinate the preparation of the registration license renewal for all registered products.
• 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.
• Develop detailed understanding of regulatory guidelines and technical requirements in the LatAm countries.

If Apply (Labeling):

• Apply labeling and non-labeling expertise for the LatAm countries to assure compliance and consistency according to regulatory requirements and Pfizer SOPs throughout Pfizer’s labeling and artwork processes.
• Ensure LLD/PIL text for the LatAm countries fulfill corporate policies and procedures.
• Coordinate the labeling (LLD/LPDs/PILs text) and non-labeling updating process of products, to ensure compliance with Pfizer labeling policy and local BoH regulations. Working with Labeling Hub and submission Manager(s), Country Regulatory Strategist (CRS), medical teams, Artwork and Labelling Implementation Management (ALIM) and Marketing team, when applicable.
• Prepare and/or coordinate dossier preparation, guaranteeing quality dossiers, fulfilling country regulations and Pfizer standards in conjunction Hub Submission Manager (HSM) and Hub Labeling Manager (HLM).
• Guarantee that dossiers are sent to the in-country Regulatory team for BoH submission in a timely manner according to labeling category and/or Regulatory strategy.
• Lead the process to answer BoH queries during text review process, coordinating with stakeholders (Rapid response teams, labeling, medical, in country regulatory strategist, ALIM and marketing, when applicable) to guarantee approval of updated labeling and/or non-labeling information reflecting global Pfizer position for products as best in class.
• Provide strategic support to the Country regulatory Heads to facilitate achievement of labeling objectives.
• Collaborate with CRS, HLM and RRHS teams to coordinate the registration of new products, line extensions and new therapeutic indications.

If Apply (Promotional Materials):

• Review promotional material expertise for MEX to assure compliance and consistency according to regulatory requirements and Pfizer SOPs throughout Pfizer’s processes.
• Complete the dossier guaranteeing quality dossiers.
• Prepare the response to answer BoH queries coordinating with stakeholders (commercial, medical, MQO and legal, if it is applicable) to guarantee the correct response reflecting Pfizer position.
• Follow up to approval the promotional material.
• Update the data bases for submission, query response, rejection or approval along the process.
• Provide strategic support commercial to new programs or projects under developing step.
• Develop detailed understanding of regulatory guidelines.
• Provide support in the inspection (internal or external) in terms of content and alignment to local regulations and Pfizer SOPs.
• Update the addendum of the Mexico SOP reflected any change in the regulation.

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:

• Education: Pharmacist degree
• Experience: About 4 years as a Senior Regulatory Sciences Analyst.

Technical Skill Requiremtents:

• Knowledge of local BoH requirements, as well as the requirements for the markets in the Cluster.
• Technical and scientific knowledge of pharmaceutical products.
• Proficiency in the English language is preferred.
• Customer-oriented
• Results-oriented
• Negotiation
• Planning
• Organized
• Decision making
• Communication
• Team player
• Change agile

If Apply (Labeling):

Key Competencies

• Successful experiences of teamwork
• Seeking and proposing alternative solutions
• Achieving goals in an inclusive manner
• Project management skills.
• Quality Focus, Detailed oriented.
• Customer-Oriented.
• Analysis and problem solving.
• Effective Communication.
• Strategically minded.
• Outward looking.
• Country/regional knowledge.
• Negotiation skills.
• Network and alliance building/ peer relationships.
• Change agile.
• Knowledge of the current framework for labeling and artwork is an advantage.
• English advanced level: Reading, writing, speaking and listening skills that are easily manifested in known contexts regarding work. Fluency in Portuguese may be an advantage.
• Proven ability to consistently deliver projects on time, cost efficiently, and of high quality
• Strong working knowledge of SOPs and compliance.

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.

• Reports to Head of Regulatory Sciences Mexico.

If Apply (Promotional Materials):

• The role has to be interaction with Mexican Ministery of Health (COFEPRIS) in terms of promotional materials.
• Marketing

Location: Mexico City

Temporary role: 12 months

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.