Regulatory Affairs Senior Manager

Regulatory Affairs Senior Manager

Amgen

Budapest, Hungary

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.

MANAGEMENT

  • 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.

REQUIREMENTS

  • Master’s degree in life science area
  • At least 6 years experience in similar position at innovative pharmaceutical company
  • Leadership experience
  • 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.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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