Regulatory Affairs Coordinator
hace 1 semana
**JOB SUMMARY**:
- Participate in the planning of Regulatory strategies for products submissions and lifecycle including also the APIs related to products under responsibility
- Coordinate and execute activities related to Dossier planning and submission -paper and/or electronic
- for initial registration and maintenance of Drug products including product renewals for the assigned portfolio(s).
- Interact with key internal stakeholders, such as Hub Regulatory Strategists, GRA Product Strategists, Submissions Management, GCMC, Quality, PGS and third-party vendors (as applicable), to ensure the regulatory strategies are executed according to the plan to permit the business continuity.
- Support the Regulatory Affairs Sr. Managers and Managers (as applicable), in the definition and execution of the regulatory strategies of assigned portfolios.
- Work in collaboration across the region to deliver efficiencies in regulatory submissions and processes.
**JOB RESPONSIBILITIES**:
- Possess understanding of the market regulatory requirements, as well as the regulatory processes.
- Coordinate the activities assigned, related to Drug Product submissions and license maintenance and Clinical Trial submissions (as applicable) to Health authorities
- Work in partnership with in-country Regulatory teams and key stakeholders including but not limited to the Regional Regulatory Hub Strategy (RRHS), Regulatory Operations, GRA, GPD, GCMC, GSCPM, to ensure the development and implementation/execution of regulatory strategies, to ensure submissions are ready to file, to permit the business continuity and to provide the necessary information to ensure internal systems and databases are updated.
- Coordinate the routine monitoring of BoH website for information related to drug product registration, line extensions and post-approval changes status. Understand local regulations and trends.
- Ensure that he/she keeps current with the agency legislations, as well as updates the regulatory information on LatAm SP & Pfizer systems/databases (as applicable).
- Coordinate and execute the review of submission ready dossiers, ensuring that assigned submissions fully meet the local regulatory requirements. This includes BoH query response.
- Support bidding processes by providing updated regulatory documents, as applicable.
- Keep updated regulatory electronic systems and tools to share accurate regulatory information with local and above country areas (GCMC, Hubs, local teams, etc.).
- Evaluate BoH regulations and its changes, keeping informed as per local processes to the Regulatory team and above country stakeholders.
- Review and approval of promotional materials (as applicable), ensuring the compliance with the due SOPs and local requirements.
- Collaborate with the labeling and artworks approval processes (as applicable), according to Pfizer procedures and local regulations.
- 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.
**QUALIFICATIONS**:
- Education: Pharmacist graduated or life science degree
- Local Regulatory experience
- minimum 2-3 years of experience as Regulatory Affairs Analyst (Human Medicinal Products)
- Proven ability to consistently deliver on time and quality standards.
- Proven ability to manage complex regulatory issues
**SKILLS**:
- Knowledge of local sanitary legislations and regulatory environment, including Clinical Trials Applications requirements (as applicable)
- Technical and scientific knowledge of human pharmaceutical products
- Proficiency in the English language
- Communication and negotiation skills
- Problem Solving
- Goals oriented
- Understanding stakeholder needs. Customer-oriented
- Network and alliance building/ peer relationships
- Strong quality and compliance orientation
- Analytical Thinking
- Ability to work under pressure
- Adaptability
- Planning
- Organized
- Team player
- Change agile
"En Pfizer tenemos el objetivo de ser tan diversos como los pacientes y las comunidades a las que servimos, a través de una cultura vibrante y enriquecida por la mezcla de nacionalidades, identidades, edades, géneros, experiências, tradiciones y capacidades. Estamos comprometidos con atraer talento basándonos en las habilidades y experiências imprescindibles para realizar el trabajo. Si te interesa sumarte a Pfizer, envíanos tu solicitud sin agregar foto, edad, estado civil o cualquier otra información que consideres innecesaria para la posición que estás aplicando.
**Trae tu auténtico ser al trabajo - Bring your authentic self to work - “**
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
LI-PFE
-
Regulatory Affairs Country Lead
hace 2 días
Santiago de Chile Johnson & Johnson A tiempo completoDiversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest...
-
Regulatory Affairs Specialist
hace 3 semanas
Chile Alimentiv Inc A tiempo completoResponsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools,...
-
Regulatory Affairs Analyst
hace 3 días
Santiago de Chile Novo Nordisk A tiempo completoCan you drive the global strategy for culture, engagement and performance management at Novo Nordisk? Do you have the interpersonal skills to navigate in a complex stakeholder landscape and are you able to motivate, set direction and deliver results? At Novo Nordisk, we are our people. And together we can make an impact. **The Position** **Main...
-
Regulatory Affairs Analyst
hace 1 semana
Santiago de Chile Novartis A tiempo completo1.066.824. That’s the number of patients we reached in 2021. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who share your determination to tackle the world’s toughest medical...
-
Regulatory Affairs Analyst
hace 1 día
Santiago de Chile Pfizer A tiempo completoJOB SUMMARY- Support the Regulatory team in the activities associated to new product registration and post approval changes during product lifecycle for the assigned portfolio.- Work in collaboration across the Country to deliver efficiencies in regulatory submissions and processes.- Interact with local Regulatory Teams, Regional Hub Teams, PGS, GCMC, GRO...
-
Regulatory Affairs Coordinator
hace 6 días
Santiago, Metropolitana, Chile UPS A tiempo completoResponsibilities:Compliance Monitoring: Monitor and instruct for compliance to UPS SCS site license requirements, ensuring adherence to DEL, MDEL, CDS, and PCR regulations.Risk Management: Promote issue resolution, risk management, continuous improvements, and project initiatives to maintain a high level of quality and regulatory compliance.Audit...
-
Regulatory Affairs Specialist, Export Countries
hace 2 días
Santiago de Chile Solventum A tiempo completo**Job Description**: Regulatory Affairs Specialist, Export Countries (Solventum) - Chile or Colombia- 3M Health Care is now Solventum- At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations...
-
Head of Regulatory Affairs
hace 3 semanas
Santiago, Metropolitana, Chile Healthcare Businesswomen's Association A tiempo completoJob Description Summary Job Purpose Responsible for the Regulatory Affairs (RA) department to obtain and maintain marketing authorizations and ensure regulatory compliance at country level. Major Activities Team and Culture Leads, develops and manages the RA department. Selects, recruits and retains high calibre staff. Sets objectives,...
-
Senior Reg Affairs Specialist
hace 2 semanas
Santiago de Chile Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Regulatory Affairs Specialist
hace 1 semana
Santiago, Metropolitana, Chile Bitfinex A tiempo completoFounded in 2012, Bitfinex is a digital asset trading platform offering state-of-the-art services for digital currency traders and global liquidity providers. We're on a mission to create the most innovative cryptocurrencies exchange. This is a unique opportunity, a rare window of time at the tipping point of financial evolution. Much like the early days of...
-
Regulatory Affairs Specialist
hace 7 días
Santiago, Metropolitana, Chile Bitfinex A tiempo completoFounded in 2012, Bitfinex is a digital asset trading platform offering state-of-the-art services for digital currency traders and global liquidity providers. We're on a mission to create the most innovative cryptocurrencies exchange. This is a unique opportunity, a rare window of time at the tipping point of financial evolution. Much like the early days of...
-
Public Affairs Coordinator
hace 5 días
Santiago de Chile Novo Nordisk A tiempo completoCan you drive the global strategy for culture, engagement and performance management at Novo Nordisk? Do you have the interpersonal skills to navigate in a complex stakeholder landscape and are you able to motivate, set direction and deliver results? At Novo Nordisk, we are our people. And together we can make an impact. **The Position** You will execute...
-
Regulatory Affairs Legal Counsel
hace 6 horas
Santiago, Metropolitana, Chile Statkraft A tiempo completoDescripción de la empresa Statkraft es una empresa internacional líder en generación hidroeléctrica y el mayor productor de energía renovable de Europa. El Grupo produce energía hidroeléctrica, eólica, solar, y con gas y suministra también calefacción urbana. Statkraft es una compañía global en gestión del mercado energético y tiene...
-
Senior Director, Corporate Affairs, Latam Area
hace 12 horas
Santiago de Chile AstraZeneca A tiempo completo**Senior Director, Corporate Affairs, LatAm Area*** Location: LatAm (all regions considered) Competitive salary and benefits package The Senior Director, Corporate Affairs, LatAm will lead the development and delivery of an integrated corporate affairs plan to drive key regional business objectives and enhance global, regional, and local alignment. As...
-
Regulatory Affairs Trainee
hace 2 días
Santiago de Chile Reckitt A tiempo completoHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...
-
Public Affairs
hace 1 semana
Santiago de Chile Mainstream Renewable Power A tiempo completoReporting to: Public Affairs & Communities Manager - Department: Corporate Affairs - Job Location: Santiago de Chile - Travel Required: Intermittent travel to sites in Chile **Company Overview** Mainstream Renewable Power is the leading independent developer of utility-scale wind and solar power plants. The company is focused on delivering a high-quality...
-
Regulatory Affairs Manager
hace 23 horas
Santiago, Metropolitana, Chile Anglo American A tiempo completoJob Description:This is a unique opportunity to work with a world-leading mining company, leveraging your expertise in environmental compliance and permitting to make a real difference. You will be responsible for coordinating permit compliance monitoring activities, managing internal tools, and preparing reports for senior management and regulatory...
-
Regulatory Consultant
hace 3 semanas
Santiago, Metropolitana, Chile Syneos Health, Inc. A tiempo completoRegulatory Consultant (CMC experience within LATAM or APAC region required) Updated: January 13, 2025 Location: Chile-Latin America - CHL-Home-Based Job ID: 25001074 Regulatory Consultant (CMC experience within LATAM or APAC region required) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate...
-
Director, Regulatory Analysis
hace 1 semana
Santiago de Chile Sovos Compliance A tiempo completo**Build your future with Sovos.** If you are looking for an opportunity where career-minded professionals can achieve success while bringing their best and whole selves to work each day, Sovos may be the company you have been looking for. Employees at Sovos operate on the leading edge of digital technology while working to improve lives and the communities...
-
Manager Public Affairs, Communications and
hace 3 días
Santiago de Chile The Coca-Cola Company A tiempo completo**Why being part of Coca-Cola Latin America?** We’re accelerating our momentum as the fastest-growing large consumer goods company in Latin America. People are our focus when we’re collaborating with our diverse network of locally connected bottling partners, and when we’re returning every drop of water we use to communities and nature. We empower our...