Career Category

Job Description

Regulatory Affairs Senior Manager (m/f/d)

Location: 1010 Vienna

The Country Regulatory Head (Senior Manager) oversees the Austrian affiliate and manages/mentors a team to deliver the regulatory country deliverables for all 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.

• Represent Global Regulatory and Strategy (GRAAS) on the extended leadership team. 

• 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).

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 the country, 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.

• Reviews and approves the promotional and non-promotional materials.

• 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 regulatory 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.

• Works with International Quality to support inspections and audits.

COMMUNICATION AND COLLABORATION

• 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.

• Represents GRAAS on the extended leadership team.

• Provides Subject Matter Expert’s support in various projects & initiatives.

• Collaborates with Global Study Operations (GSO) to support local planning and execution for clinical studies in accordance with national, legal and regulatory requirements.

• Collaborates with International Distribution Quality (IDQ) to implement processes and procedures to meet local Regulatory and Quality procedures (Local Quality Management plan).

• Collaborates with local Healthcare Compliance (HC) Lead to support the compliance framework, the roll out of Corporate Compliance initiatives and the local compliance trainings.

EXTERNAL INTERACTIONS

• 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.

• Manages Distributors, Functional Service Providers (FSP) and Vendors and keeps an ongoing relationship, as required.

HEALTH AUTHORITY INTERACTIONS

• Leads, contributes to strategy and attends HA meetings.

BASIC QUALIFICATIONS

• Doctorate degree and 2 years of directly related experience OR

• Master’s degree and 6 years of directly related experience OR

• Bachelor’s degree and 8 years of directly related experience

KNOWLEDGE AND SKILLS

Scientific and Technical

• Experience working with local/regional regulatory agencies, and CROs, local service providers, distributors and/or contractors 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.
   

Others

• Demonstrate strong teamwork ability.

• Good communication skills German and English - 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.

We offer an annual minimum base pay of € 70.000 gross (full time/All-In) per year and attractive benefits (e.g. office location in Vienna 1010, flexible working hours/remote work, bonus payment, pension plan, lunch allowance ...). The final compensation package will depend  on your qualification and experience.

We are looking forward to your application via our online tool!