Regulatory Group Head LATAM

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.