Head of Regulatory Affairs Brazil São Paulo (SP)
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Job Location:
Santo Amaro - Brazil
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Description Summary
Sandoz operates with a focus on bringing healthcare access to patients. As a global leader in generic and biosimilar medicines we serve 9 million patients per year in Brazil. The Head of Regulatory Affairs in Brazil directs the development of submission of product registration progress reports supplements amendments and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval on of new drugs biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes line extensions technical labeling appropriate regulations and interpretations. Coordinates reviews and may prepare reports for submission.Job Description
Major accountabilities:
- Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions.
- Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document or their equivalents including identification of gaps or risks in global strategic plan for assigned regions.
- Partners with regions to align on regulatory strategy in order to fulfil business objectives -Implements RFP across assigned regions.
- Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
- Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
- Develops and implements plans for timely response to HA requests and coordinates responses.
- May serve as local HA liaison depending on location (e.g. FDA or EMA).
- Drives coordination planning and submission of dossiers in assigned regions worldwide.
- Review of global dossier summary documents.
- Develops and implements plans to avoid/minimize clock stops during submission review.
- Reviews approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
- Reviews and submits Risk Management Plans.
- May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.
- Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.
- Contributes to and often leads the development of departmental goals and objectives.
- Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
- Identification of main HA issues -Participation in relevant regulatory Boards leading to valuable input from these Boards.
- Successful Participation in HA interactions to achieve business objectives.
- Adherence to Sandoz policy and guidelines -Project & stakeholder feedback
Minimum Requirements:
Work Experience:
- Cross Cultural Experience.
- Functional Breadth.
- Project Management.
- Operations Management and Execution.
- Representing the organization.
Skills:
- Clinical Trials.
- Cross-Functional Teams.
- Detail Oriented.
- Drug Development.
- Lifesciences.
- Negotiation Skills.
- Problem Solving Skills.
- Regulatory Compliance.
- Risk Management.
Languages :
- English.
Why Sandoz
Sandoz is the global leader in Biosimilar and Generic medicines a segment of the healthcare industry that delivers 80% of the worlds medicines at 30% of the cost touching the lives of more than 1 billion people across 100 countries! While we are proud of our achievements we have an ambition to do more so that everyone can achieve the basic humanrightof good health.
With investments in new development capabilities production sites new acquisitions and partnerships wehave the opportunity toshape the future of Sandoz and help even more people gain access to low-cost high-quality medicines sustainably.
Join us help us make healthcare fairer and faster.
Commitment to Diversity & Inclusion:
We arecommitted to building an outstanding inclusive work environment and diverseteamsrepresentative of the patients and communities we serve.
Skills Desired
Clinical Trials Cross-Functional Teams Detail-Oriented Drug Development Lifesciences Negotiation Skills Problem Solving Skills Regulatory Compliance Risk ManagementRequired Experience:
Director
