Regulatory Group Head LATAM Brazil Regulatory Lead

Career Category

Job 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 Amgens 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 staffin the country delivers on local and/or regional regulatory and compliancestrategies/goals across their country(ies).
• Represent GRAAS on the country management team(s).
• Provide local input todevelop 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 Amgens 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
• Masters degree and 8 years of directly related experience OR
• Bachelors degree and 10 years of directly related experience
• AND 4years 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.