Regulatory Affairs Manager

hace 2 semanas

Buenos Aires, Argentina Bristol-Myers Squibb A tiempo completo

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades** **. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma **recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley.**

**Position Summary**:
Collaborate in regulatory strategies for submissions of NDA's and Clinical trials to accelerate new science to patients at the time compliance is respected.

Execute local country submissions for new registrations, product renewals and variations.

Ensure regulatory compliance at a local level

Maintain established brands in line with strategy

Local team engagement and alignment

**Position Responsibilities**
- Participate in the review and formulation of the country regulatory strategy for new products registration and life cycle management in alignment with business goals.
- Communicate regulatory submission dates, regulatory status, nature of changes, track and inform of minor/significant product information changes to all relevant parties
- Maintain strong relationships with other functional areas (i.e., Medical, Supply, Commercial, QA/QC).
- Plan and track activities related to regulatory submissions
- Responsible for the in-time review and approval of 100% promotional materials.
- Management of Health Authority (HA) requisitions.
- Identify opportunities to improve departmental functions/processes.

**Degree Requirements**:

- Science related degree
- Fluent English skills
- Excellent technology profile
- Transparent communication
- Team Leader

**Key competency requirements**:
Up-to-date regulatory knowledge required to do the job as described above, and experience with new drug development work.

Fluent in English

Good communication and interpersonal skills

Li-Hybrid

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

  • Regulatory Affairs Sr Manager

    hace 4 semanas

    Capital Federal, Buenos Aires, Argentina Medison Pharma A tiempo completo

    Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases._ - Medison is rapidly growing in the international markets...

  • Regulatory Affairs Senior Lead

    hace 18 horas

    Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completo

    Job ResponsibilitiesThe Regulatory Affairs Sr Manager will oversee all regulatory activities in Argentina, covering RA, PV and QA areas.He/she will play a key role in establishing our Quality Management System and procedures for GxP activities in the territory.The successful candidate will thrive in a dynamic environment, working effectively within...

  • Regulatory Affairs Specialist

    hace 19 horas

    Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completo

    About Medison PharmaAt Medison Pharma, we are committed to providing access to innovative therapies for patients worldwide. As a global pharmaceutical company, we commercialize highly effective treatments across international markets.We have over 25 years of established operations in Israel and a strong global infrastructure. Our international markets HQ is...

  • Senior Manager Regulatory Affairs

    hace 18 horas

    Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completo

    Key Responsibilities and RequirementsThe ideal candidate will have a strong background in Regulatory Affairs, Pharmacovigilance and Quality Assurance.A minimum of 6+ years pharmaceutical industry experience with at least 4 years in Regulatory Affairs area, Technical Officer (responsible pharmacist) and PV in Argentina – Experience in Uruguay, Chile, and...

  • Regulatory Affairs Leader

    hace 5 días

    Buenos Aires, Buenos Aires C.F., Argentina Takeda A tiempo completo

    Job OverviewTakeda is seeking a highly skilled Regulatory Affairs Leader to join our team.Key Responsibilities:Define and lead area regulatory strategies to maximize regulatory success and enable patient access.Effectively communicate regulatory strategies, submission plans, and timelines with cross-functional stakeholders.Liaise with global regulatory teams...

  • Global Regulatory Compliance Manager

    hace 19 horas

    Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completo

    Job DescriptionWe are looking for an experienced Regulatory Affairs Manager to lead our team in Argentina (South Cone - Chile, Uruguay, Paraguay). The successful candidate will have a strong background in regulatory affairs, pharmacovigilance, and quality assurances.The Regulatory Affairs Manager will be responsible for building and maintaining our Quality...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Buenos Aires, Argentina Medtronic A tiempo completo

    **Careers that Change Lives **In this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or RA...

  • Regulatory Affairs Strategist

    hace 7 días

    Buenos Aires, Buenos Aires C.F., Argentina Boston Scientific A tiempo completo

    About UsAt Boston Scientific, we are a global leader in medical science for over 40 years. Our mission is to advance science for life by transforming lives through innovative medical solutions that improve patient outcomes, create value for our customers, and support our employees and the communities we serve.">The RoleWe are seeking a Regulatory Affairs...

  • Regulatory Affairs Specialist, Latam

    hace 4 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    POSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...

  • Pharmaceuticals Regulatory Coordinator

    hace 19 horas

    Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completo

    Regulatory Affairs ManagerWe are seeking an experienced Regulatory Affairs Manager to join our team in Argentina (South Cone - Chile, Uruguay, Paraguay). The successful candidate will have a strong background in regulatory affairs, pharmacovigilance, and quality assurances.The Regulatory Affairs Manager will be responsible for building and maintaining our...

  • Regulatory Affairs

    hace 3 semanas

    Buenos Aires, Argentina International Flavors & Fragrances A tiempo completo

    This position is key and strategic to the Global Regulatory Affairs organization to meet the strategy to be a premier partner to our customers. Customers need detailed information about our products, quality systems, 3rd party certifications, regulatory compliance and others. In this role you will be responsible to deliver documentation; answering inquiries...

  • Regulatory Affairs

    hace 4 semanas

    Buenos Aires, Argentina Serviap A tiempo completo

    **Job Description Form** Consumer - Regulatory Affairs **Department / Project **( OTC+Cosmetics+Food and **Job Title **Team Lead Dietary Supplements) **Duties and Responsibilities** **Regulatory Strategist/ Specialist**: - Complete Regulatory Support - providing regulatory services/ support for client projects for assigned markets. - Markets assigned...

  • Regulatory Affairs Manager

    hace 2 semanas

    Buenos Aires, Argentina Bioceres Crop Solutions A tiempo completo

    We are looking for a Regulatory Affairs Manager to join our Bioceres Crop Solutions team! The mission of the position is to give support and execute Bioceres regulatory strategy for biotechnological traits and products on target crops, in order to obtain and maintain regulatory approvals in all relevant locations at a timely manner. Be the primary interface...

  • Senior Scientist, Regulatory Affairs, Latam

    hace 3 semanas

    Buenos Aires, Argentina Seqirus A tiempo completo

    Please present resumes in English **The Opportunity** You will be a technical specialist within LATAM Region and will have the opportunity to shae the vision and goals for Global Regulatory Affairs and Seqirus, by providing specialist, regional advice and support. You will partner with other functions in Regulatory Affairs (e.g. Global Regulatory Leads,...

  • Medical Device Regulatory Affairs Lead

    hace 3 días

    Buenos Aires, Buenos Aires C.F., Argentina Boston Scientific Gruppe A tiempo completo

    Job DescriptionWe're seeking a highly skilled Regulatory Affairs Specialist II to join our team at Boston Scientific Gruppe. In this role, you'll work closely with cross-functional teams to develop local strategies for regulatory approval. Your responsibilities will include coordinating, compiling, and submitting regulatory submissions for new products,...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Buenos Aires, Argentina Johnson & Johnson A tiempo completo

    At **Johnson & Johnson, **the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & 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...

  • Engineer /Scientist I Regulatory Affairs Argentina

    hace 3 días

    Buenos Aires, Buenos Aires C.F., Argentina Mondelez International A tiempo completo

    **Job Description**:**Are You Ready to Make It Happen at Mondelez International?****Join our Mission to Lead the Future of Snacking.Make It With Pride.**You execute the regulatory affairs strategy for your respective category or categories and geographical area using your technical and regulatory knowledge.You ensure our policies, regulatory programs and...

  • Regulatory Affairs Specialist Ii

    hace 6 días

    Capital Federal, Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

    **Additional Locations**: N/A **Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to...

  • Regulatory Affairs Specialist II Expert

    hace 3 días

    Buenos Aires, Buenos Aires C.F., Argentina Boston Scientific Gruppe A tiempo completo

    OverviewBoston Scientific Gruppe, a leader in medical science for over 40 years, is committed to solving the most pressing challenges that matter. Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient outcomes and create value for our customers.About the RoleWe are seeking an experienced...

  • Regulatory Affairs Associate

    hace 6 días

    Buenos Aires, Buenos Aires C.F., Argentina IQVIA Argentina A tiempo completo

    About the JobThe Regulatory Affairs Associate will support the site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines.Key ResponsibilitiesReview documents for completeness, consistency, and accuracy, under guidance of senior...