Responsable Affaires Réglementaires Senior - Paris, France - Pfizer

Pfizer

Entreprise vérifiée

Paris, France

il y a 1 semaine

Posté par:

Sophie Dupont

beBee Recruiter

Description

JOB SUMMARY

Oversee and optimise regulatory (development, registration, maintenance) for the portfolio of products under his/her responsibility, in accordance with regulatory requirements, Group procedures and in accordance with the strategies of Business Units, and perform regulatory intelligence.

Performs regular reporting of his/her activities conducted on his/her portfolio to the Head of Regulatory Sciences.

MANAGEMENT OF TEMPORARY AUTHORISATIONS FOR USE (ATU) - Early Access to Patient

Acts as the Project Co-Lead and as the main contact of Health Authorities
Coordinates the dossier preparation in cooperation with local and global Project Team
Elaborates the Protocol of Therapeutic Use (PUT), Therapeutic Information Leaflet (NIT) and Product Information (as applicable) in cooperation with local and global Project Team
Prepares/submits authorisations for importation and follows up on them
Actively participate in the implementation of the ATU
Participates to the postATU strategy and manages the end of the ATU regulatory related activities

MANAGEMENT OF TEMPORARY RECOMMENDATIONS FOR USE (RTU/CPC)

Acts as the Project Co-Lead and as the main contact of Health Authorities
Coordinates the dossier preparation in cooperation with local and global Project Team

in response to Health Authorities request

Drafts the Patient Monitoring Protocol in cooperation with local and global Project Team
Ensures followup with the Health Authorities and the Project Team
Management of the postRTU activities with the local project team

MANAGEMENT OF CLINICAL STUDY AUTHORISATIONS

Validates the clinical trial authorisation dossiers prepared by Global team / Alliance Partners (APs) and submits them to the Health Authorities in accordance with deadlines.
Oversees the followup of the evaluation and uses all resources necessary to obtain the approval of dossiers.
Is recognized as an expert in the field and for this reason is consulted by global teams or by Aps for certain specific problems.

VALIDATION OF PRODUCT INFORMATION:
SPC, LEAFLET AND LABELING / PACKAGING ARTICLES / LEGAL STATEMENTS:

Validates the print proofs of packaging articles transmitted by the Pharmaceutical team based on MA appendices.
Ensure communication of updated product information.
Validates Vidal monographs according to the Vidal Chart.

ADVISING, REGULATORY INTELLIGENCE AND QUALITY

Collaborates with the Market Access Department in the creation of the price/reimbursement dossier.
Performs regulatory intelligence, particularly on the therapeutic fields in which Pfizer is active, and distributes pertinent information to orient the strategic and commercial activities, particularly through ANSM commission reports.
Writes/updates the procedures related to the activity of the department in accordance with regulations and global procedures.
Is responsible for updating all regulatory databases in accordance with Pfizer procedures on the products in his/her portfolio.
Prepares and participates in audits and inspections related to regulatory activity.
Represents the RA department externally, directing and contributing to crossdisciplinary groups for regulatory matters.
Contributes actively to working groups (Global, Regional or local) in order to harmonise or optimise our practices within Pfizer.
Is recognised as an expert of regulatory questions in specific therapeutic areas, regulatory topics and for all interactions with Regulators (as appropriate).
Represents the Head of Regulatory Sciences during EU and global strategic and regulatory meetings e.g. ERF, ERSG, etc.
Acts as Pfizer's representative externally in working groups and meetings related to strategic regulatory topics (e.g. LEEM, NèreS, AFAR, etc).
Provides key regulatory insights and information to other departments on new strategies, paths or business focused opportunities to maximize the value of each innovative asset.
Approves regulatory documents on behalf of the Head of Regulatory Sciences according to procedures and delegation process.
Recruits and supervises trainees/apprentice, if applicable.

QUALIFICATIONS / SKILLS

Technical Skills

Rigor
Respect for rules and procedures, committed to high standards of quality and efficacy
Showing interest and curiosity for knowledge about the organisation and/or the external environment, to understand their evolution and enrich Pfizer's practices
Clarity and precision in writing and expression
Communication: Explaining, interpreting and sharing information
Adapting his/her communication to different interlocutors, who might have divergent interests
Show initiative and autonomy in his or her sphere of responsibility
Knowing how to adapt quickly to an imposed change
Cultivate a network of partners, both internal and external, involved in his or her activity

Qualifications:

EDUCATION AND PROFESSIONAL EXPERIENCE: