The Country Regulatory Head (Sr. Manager) oversees the affiliate 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).
Provide local input to develop and execute the regulatory strategies and effective key regulatory agency(ies) interactions.
Supervise and oversight for one regulatory affairs colleague.
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.
Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with own team and local cross-functional team.
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.
Oversees the affiliate/local office compliance framework to comply with local codes and legislation and Amgen policies and procedures.
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.
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.
Master’s degree in life science area
At least 6 years experience in similar position at innovative pharmaceutical company
Fluent English knowledge
Demonstrate strong team work ability.
Good communication skills - both oral and written.
Good negotiation and Influencing skills.
Ability to anticipate and prevent potential issues.
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
Cultural awareness and sensitivity to achieve results across both regional, country and International borders.
Ability to Manage multiple activities and set priorities.