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 mínimal 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 moni