Description
**Regulatory Group Head LATAM** , **Director**
Facilitate patient access to Amgen products in countries through executing on our filing and license maintenance plans (as applicable); providing strategic country/regional regulatory guidance on regional regulatory mechanisms to optimize product development and approvals; aligning with key cross-functional partners; integrating Amgen’s commercialization process, and continuously improving our processes and developing our talent.
**The Country Regulatory Head (Director) oversees a larger affiliate or Hub and manages/mentors a team to deliver the regulatory country(ies) deliverables. This role can also be assigned to one or more Amgen products.**
+ First point of contact for interactions with local regulatory agency(ies).
+ Ensure that the local Regulatory staff in the country delivers on local and/or regional regulatory and compliance strategies/goals across their country(ies).
+ Represent GRAAS on the country management team(s).
+ Provide local input to develop and execute the regulatory strategies and effective key regulatory agency(ies) interactions.
+ Supervise and oversight for one or more regulatory staff.
+ Manage and liaising with distributors (if applicable).
**Key Activities**
**STRATEGY AND EXECUTION**
+ Translates global and regional business plans to local regulatory objectives.
+ Is the senior point of contact for regulatory advice on commercial and medical projects within the affiliate and sub-regional management teams
+ Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with own team and local cross-functional teams.
+ Executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.
+ Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
+ Creates, reviews and approves source text for country labeling, and owns the country artwork based on source text (where applicable).
+ Reviews and approves the promotional and non-promotional materials (where applicable).
+ Monitors changes in the local Trade Associations / national legislation and forwards information to local/regional groups communicating the impact to Amgen.
+ Monitors the external regulatory environment to help inform/advise in the regulatory decision making.
**MANAGEMENT**
+ Oversees the affiliate / local office compliance framework to comply with local codes and legislation and Amgen policies and procedures (with minimal supervision).
+ Provides advice, guidance and support to Regulatory staff.
+ Recruits and retain talented regulatory staff.
+ Provides coaching, mentoring and development of Regulatory staff.
+ Ensures staff are compliant with Amgen corporate and departmental training.
+ Disseminates relevant information to the team, as appropriate.
+ Is accountable for delivery against goals assigned to the country.
+ Provides input to budget and headcount planning.
+ Leads/Participates in local regulatory process improvements, initiatives, and trainings
+ Tracks metrics for team deliverables.
+ Ensures approval and maintenance of local products, clinical trials and pharmaceutical company licenses.
+ Works with International Quality to support inspections and audits.
**COMMUNICATION AND COLLABORATION**
+ Collaborates with Global Study Operations (GSO) to support local planning and execution for clinical studies in accordance with national, legal and regulatory requirements (where appropriate).
+ Ensures that country(ies) develops, implements and maintains processes and procedures to meet local Regulatory and Quality procedures (Local Quality Management plan).
+ Ensures local implementation of key regulatory projects.
+ Exchanges regulatory information with other regulatory colleagues on an ongoing basis and provides advice on regional regulatory considerations in a timely manner.
+ Partners where required with GRAAS colleagues to support the regulatory development, registration, and lifecycle management of all Amgen molecules.
+ Works closely with cross-functional, local and regional colleagues to deliver Amgen goals in accordance with national / regional regulatory requirements.
+ Communicates clearly and in a timely manner with key stakeholders across the business.
+ Provides **SME support in projects** initiatives.
**EXTERNAL INTERACTIONS**
+ Manages Distributors, Functional Service Providers (FSP) and Vendors and keeps an ongoing relationship, as required.
+ Engages with local trade associations to shape the external environment, monitors national legislation and provides feedback to regional and local colleagues in a timely manner.
+ Participates in local industry and trade association groups relating to Amgen business activities and Regulatory Affairs.
**HEALTH AUTHORITY INTERACTIONS**
+ Leads, contributes to strategy and attends HA meetings.
**COMPLIANCE**
+ Acts as the local compliance lead for the country(ies), if applicable.
+ Supports the monitoring, auditing and self-assessment activities under the compliance framework.
+ Represents Compliance and GRAAS on country and/or sub-regional management teams.
+ Coordinates roll out of Corporate Compliance initiatives and local compliance trainings with relevant internal groups.
+ Identifies and oversees the development and implementation of any country specific compliance procedures.
+ Acts as key contact for Healthcare Compliance & represents country in Compliance Committee.
**Knowledge and Skills**
**Scientific and Technical**
+ Experience working with CROs, local service providers, distributors and/or contractors and regional regulatory agencies, as applicable.
+ Ability to lead teams and develop effective teams.
+ Ability to understand and communicate scientific/clinical information.
+ Understanding of regulatory activities and how it affects projects and processes.
+ Ability to set organizational direction & champion change and continuous improvement.
+ Ability to anticipate and mitigate future strategic issues & uncertainties.
+ Ability to input effectively on multi-functional country management teams.
**Education & Experience (Basic)**
+ Doctorate degree and 4 years of directly related experience OR
+ Master’s degree and 8 years of directly related experience OR
+ Bachelor’s degree and 10 years of directly related experience
+ AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
**Education & Experience (Preferred)**
+ Degree and in-depth regulatory experience and/or related to the country(ies).
+ Depth knowledge of country(ies) legislation and regulations relating to medicinal products.
A Amgen não discrimina em suas oportunidades de emprego com base em sexo, raça, cor, idade, nacionalidade, ideias políticas ou religiosas, gênero, orientação sexual, identidade de gênero, nível e tipo deficiência, origem étnica ou qualquer outra categoria protegida por lei.
