Regulatory & Quality Affairs Pharmacist

Work Schedule

Environmental Conditions

Job Description

Join Us as a Senior Regulatory Affairs Specialist Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

Position Overview

We are seeking an experienced Pharmacist to take on responsibilities in Regulatory Affairs and Quality Assurance at our facility in Vargem Grande Paulista Brazil. This is a Coordinator/Specialist level position without direct reports ideal for a professional who thrives in a hands-on role ensuring compliance and quality standards within the pharmaceutical industry.

As part of our global team youll have the opportunity to serve as the lead over several countries/projects in providing innovative solutions including regulatory expertise and client interface. As a Regulatory Affairs Senior Specialist youll provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization. You will provide strategic expedient and efficient preparation of client deliverables that meet current local regional and ICH regulatory and technical requirements. Additionally you will act as a liaison with internal and external clients in the provision and marketing of these services.

Key Responsibilities

Participate in regulatory affairs activities including preparation submission and maintenance of dossiers for pharmaceutical products with emphasis on biological products.

Ensure compliance with national and international pharmaceutical regulations including ANVISA requirements and global guidelines.

Act as the primary contact for regulatory authorities and certification bodies.

Oversee quality assurance processes including audits inspections and corrective/preventive actions.

Develop implement and monitor Standard Operating Procedures (SOPs).

Collaborate with cross-functional teams to ensure product quality and regulatory compliance.

Support continuous improvement initiatives in quality systems.

Provides senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations local and regional requirements.
Acts as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.
Participates in project management activities to support the provision of regulatory services and acts as liaison with internal and external clients in the provision of marketing these services.
Provides matrix/project leadership training and guidance to junior team members to support understanding of regulations impact on study assessment of risk etc. and to achieve a specific goal and/or project deliverables.
May provide input on peformance reviews to management.
Ensures adherence to project budgets time schedules and scope of work.
Ensures compliance with relevant organizational and regulatory SOPs and WPDs.
Contributes to business development activities including project budgeting/forecasting.

Education and Experience Requirements:

Degree in Pharmacy (mandatory).

Active CRF registration (mandatory).

Minimum of 5 years of experience in the pharmaceutical industry specifically in Regulatory Affairs and Quality some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Proven experience with biological products.

Strong knowledge of Brazilian pharmaceutical regulations.

Knowledge Skills and Abilities:
Excellent English language (written and oral) communication skills as well as local language where applicable
Great attention to detail and quality as well as excellent editorial/proofreading skills
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Strong computer skills including the use of Microsoft Office (Word Excel Power Point Outlook); capable of learning new technologies
Solid organizational time management and planning skills to create and follow timelines conduct long-range planning adapt to changing priorities and handle multiple projects
Strong negotiation skills
Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
Strong understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization licensing lifecycle management; expert knowledge of ICH and other
global regulatory guidelines; good understanding of a regulatory speciality areas such as preclinical clinical CMC publishing etc.
Strong understanding of medical terminology statistical concepts and guidelines
Excellent analytical investigative and problem-solving skills
Solid understanding of budgeting and forecasting

Location

Vargem Grande Paulista São Paulo Brazil.

Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.