Regulatory Affairs Manager
hace 4 semanas
As a Regulatory Affairs Manager, you will lead the establishment of Regulatory Affairs management in the LATAM region. You will be responsible for all aspects of the LATAM Regulatory Strategy, supporting the growth of the pipeline in LATAM.
Key Responsibilities- Lead Pharmanovia's Regional operations strategically aligned to growth plans in LATAM
- Establish regional infrastructure and ensure regulatory compliance with the national competent authority legislation for the marketing and distribution of Pharmanovia's products
- Lead the successful launch of new product development by ensuring the timely roll out of new applications and post approval changes regionally
- Establish regulatory strategies and develop submissions for CTAs, CTA exemptions, NDA submission, pre-NDA meetings, life-cycle management and labelling management
- Regional regulatory lead representing due diligence assessments and development opportunities
- Ensure planning and optimal organisation of regional regulatory activities
- Drive growth opportunities in LATAM through strategic planning and in-depth understanding of the regulatory framework in LATAM
- Ensure full readiness and compliance of the local entity and all related activities for products commercialization
- Serve as a critical member of the Regulatory Affairs team providing LATAM-focused product development strategies and the registration of foreign-developed products
- Lead interactions and submissions with the COPEFRIS and related Health Authorities for LATAM markets
- Monitor, identify, and communicate regulatory environmental trends and regulation development which would influence Pharmanovia's growth opportunities
Candidates with at least 5 years of regulatory affairs experience within a multinational pharmaceutical company are likely to have the skills required to be successful in this role. We are also looking for:
- Master's degree or above in pharmacy, medicine, or chemical sciences
- Great IT skills including MS Word, Excel, Project, PowerPoint, and Outlook
- Proven record and recent experience of CTA/NDA and associated strategy in LATAM
- Good understanding of the regulatory infrastructure required for the marketing and distribution of pharmaceutical products
- Strong knowledge of local regulatory framework and guidelines
- Must be able to independently present complex global regulatory strategies internally and to Pharmanovia's partners
- Expertise in writing scientific and technical documents, and strong attention to detail with proofreading materials
- Overall global expertise, professional gravitas, and strong influence skills and will display personal and professional maturity
- Data-driven in decision making with the ability to analyse complex situations, focus on the key issues, and communicate within the team and upwards with clarity and concisely
- Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
- Strong networking, planning, and organisational skills with a demonstrated capability to manage complex projects with short timelines
- Ability to work successfully within cross-functional teams
- Excellent professional communication skills, both written and verbal
- Fluency in both Spanish and English languages required
We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme, and hybrid working.
-
Regulatory Affairs Manager
hace 1 mes
Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoJob Title: Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences Mexico, S. de R.L. de C.V. in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with applicable regulations and...
-
Regulatory Affairs Manager
hace 4 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob Title: Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to ensure compliance with applicable regulations and maximize regulatory success.Key...
-
Regulatory Affairs Manager
hace 1 mes
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with applicable regulations and guidelines.Key...
-
Regulatory Affairs Senior Manager
hace 3 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob Title: Regulatory Affairs Senior ManagerAbout the Role:We are seeking a highly skilled Regulatory Affairs Senior Manager to join our team at Gilead Sciences. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to ensure compliance with applicable regulatory requirements.Key...
-
Regulatory Affairs Specialist
hace 4 semanas
Ciudad de México, Ciudad de México Mccormick & Company A tiempo completo**Scientific and Regulatory Affairs Manager LATAM**Mccormick & Company, a world leader in the spice, flavor and seasonings industry, is seeking a full time Scientific and Regulatory Affairs Manager LATAM. This new hire will work in our Mexico City location.We create differentiating flavors consumers prefer with unmatched quality, science, innovation and...
-
Regulatory Affairs Sr. Manager
hace 4 semanas
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob Title: Regulatory Affairs Sr. ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Sr. Manager to join our team at Gilead Sciences. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to maximize regulatory success and ensure compliance with applicable regulatory...
-
Regulatory Affairs Manager
hace 1 semana
Ciudad de México, Ciudad de México Solventum A tiempo completoJob OverviewSolventum is seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico. As a Regulatory Affairs Specialist, you will be responsible for providing general regulatory support for medical products sold in Mexico, including managing medical product licenses with COFEPRIS, reviewing and approving product labeling and...
-
Regulatory Affairs Specialist
hace 3 semanas
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoWe are seeking a Regulatory Affairs Specialist to contribute to ensuring the delivery of regulatory activities on a global level.Key Responsibilities:To assist in the production of client administrative documents for regulatory submissions.To compile regulatory dossiers in accordance with national requirements and ensure their accuracy.To manage systems and...
-
Regulatory Affairs Specialist
hace 3 semanas
Ciudad de México, Ciudad de México Qiagen A tiempo completoRegulatory Affairs Manager RoleWe are seeking an experienced Regulatory Affairs Manager to lead and undertake regulatory responsibility for Mexico and Central Americas to ensure our IVD products comply with regional regulations and laws.This role involves developing and implementing regulatory strategies to facilitate product approvals, registrations, and...
-
Regulatory Affairs Manager
hace 4 semanas
Ciudad de México, Ciudad de México Gilead Sciences, Inc. A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences, Inc. in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for developing and executing regulatory strategies to ensure compliance with applicable regulations and maximize regulatory success.This is an exciting...
-
Regulatory Affairs Expert
hace 3 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoIn this role as a Regulatory Affairs Expert, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...
-
Regulatory Affairs Specialist
hace 3 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoIn this role as a Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...
-
Regulatory Affairs Manager
hace 7 días
Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoDescriptionAt Gilead Sciences Mexico, S. de R.L. de C.V., we are seeking a talented Regulatory Affairs professional to join our Regulatory Affairs team. This is a unique opportunity to work on advancing therapeutics while ensuring regulatory compliance.This role involves close collaboration with various stakeholders to define, develop, and execute regulatory...
-
Regulatory Affairs Strategist
hace 21 horas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoIn a pivotal role at Thermo Fisher Scientific, the Sr Regulatory Affairs Specialist will be part of our Regulatory Liaison team, spearheading communications with regulatory agencies as part of centralized regulatory submissions. This includes collaboration with regulatory affairs leads to provide strategic guidance and technical/project leadership on a...
-
Regulatory Affairs Specialist
hace 3 semanas
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoWe are seeking a Regulatory Affairs Specialist to ensure the delivery of regulatory activities on a global level.Key ResponsibilitiesContribute to the production of client administrative documents for regulatory submissions.Compile regulatory dossiers in accordance with national requirements.Manage systems and administer regulatory processes.Track and...
-
Regulatory Affairs Specialist
hace 7 días
Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completoPosition for Novo Nordisk GBS MexicoPursue a challenging career in regulatory affairs with Novo Nordisk's Global Business Service Centre in Mexico City.We are seeking a highly skilled Regulatory Affairs Coordinator to support the compilation, submission, and approval of Country Specific Submissions files for responsible countries.Key ResponsibilitiesSupport...
-
Regulatory Affairs Specialist
hace 4 semanas
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoRegulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a Regulatory Affairs Specialist, you will be responsible for managing post-approval activities for the Canadian market, including life cycle management, change controls, and regulatory submissions.Key Responsibilities:Manage...
-
Regulatory Affairs Professional
hace 3 semanas
Ciudad de México, Ciudad de México Icon Plc A tiempo completoThe Regulatory Affairs Specialist will contribute to the preparation, compilation, and submission of regulatory documents, including CT/IND, MAA, and NOA. Key Responsibilities:- Regulatory Document Preparation: Prepare and submit regulatory documents in a timely and accurate manner.- Collaboration with Teams: Work with the Regulatory Submissions team and...
-
Regulatory Affairs Sr. Manager
hace 4 semanas
Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoJob DescriptionWe are seeking a highly skilled Regulatory Affairs Sr. Manager to join our team at Gilead Sciences Mexico, S. de R.L. de C.V. This is an exciting opportunity for an experienced regulatory professional to contribute to the success of our organization.Key ResponsibilitiesDevelop and execute regulatory strategies to ensure compliance with...
-
Regulatory Affairs Specialist
hace 4 semanas
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoRegulatory Affairs OfficerWe are seeking a Regulatory Affairs Officer to manage post-MAA activities (Life Cycle Management) for the Canadian market. This role involves coordinating and performing regulatory steps until closure of change controls, compiling regulatory dossiers, and documenting and tracking regulatory submissions.ResponsibilitiesManage...