Regulatory Affairs Manager - Maghreb

Created by: Amgen
Added: 15.10.2020
Website: www.amgen.com

Advert description

Regulatory Affairs Manager - Maghreb

Local Regulatory Affairs provides country regulatory expertise and execution for the development, registration, and lifecycle management of all Amgen molecules.

The Local Regulatory Representative (Manager) is assigned to all Amgen products in Maghreb Cluster (Algeria, Morocco, Tunisia & Libya). He/she oversees the affiliate and manages a Snr Associate as to deliver all regulatory deliverables in line with cluster commercial objectives and business goals

Assist in aligning local regulatory requirements with Amgen’s corporate standards:

  • Act as the first point of contact for all interactions with regulatory agencies in Maghreb cluster
  • Ensures the regulatory team member delivers on local goals across countries
  • Represent regulatory in cluster management team
  • Supervise and oversight for one regulatory staff
  • Manage and liaise with distributors
  • Provide national/regional input to and execute regulatory strategies.
  • Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
  • Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.

Key Responsibilities

Strategic and Execution

  • Translated regional business plans to local regulatory objectives
  • Is point of contact for regulatory advice on commercial and medical projects within affiliate
  • Contributes to filing plan both new MAAs and life cycle maintenance advising and discussing within function and locally across functions
  • Executes the filing plan
  • Ensures regulatory submissions and approvals are done on time and meet both amgen corporate and local regulatory requirements
  • Reviews and approves promotional and non-promotional materials
  • Monitors changes in local trade associations and share information to local affiliate
  • Monitors external regulatory environment to help inform and advise on regulatory decision making
  • Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
  • With general supervision, 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.
  • Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
  • 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.
  • Ensures/supports regulatory product compliance (e.g. IMR, PMCs, pediatric and other agency commitments).

Management

  • Retains and recruits talented regulatory staff
  • Provides coaching and mentoring and development of staff
  • Ensure staff are compliant with amgen corporate and departmental training
  • Disseminates relevant information to team as appropriate
  • Is accountable for delivery against goals assigned to cluster
  • Provides inputs on budget and headcount planning
  • Leads and 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
  • Works with local safety officers to ensure safety reporting on time.

Health Authority Interactions 

  • Acts as the point of contact with regulatory agencies in fulfilling local obligations.
  • Leads, Participates & contributes to local agency interactions and their preparation and to strategy of meetings .

Communication and Collaboration 

  • Works closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.
  • Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
  • Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.
  • Partners with peers to ensure consistency on procedures.
  • Acts as contact and create relationships with Agency staff
  • Establishes regular contacts and interactions with Distributors

Country specific activities

  • Assists locally in Healthcare Compliance activities where applicable.
  • Participates in local regulatory process improvements, initiatives and training.
  • Oversees external vendor/contractor relationships where applicable.
  • Assists locally in Healthcare Compliance, QA or pharmacovigilance activities where applicable.

Scientific and Technical

  • Knowledge of Regulatory principles.
  • Working with policies, procedures and SOP’s.
  • Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
  • General knowledge of national legislation and regulations relating to medicinal products.
  • General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
  • Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
  • Understanding of drug development.

Others Skills

  • Demonstrate strong team work ability.
  • Good communication skills - both oral and written.
  • Good negotiation and Influencing skills.
  • Ability to understand and communicate scientific/clinical information.
  • 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.

Education & Experience (Basic)

Doctorate or Master’s degree (scientific area) and 3 - 6 years of directly related experience OR
Bachelor’s degree (scientific area) and 5 – 8 years of directly related experience

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

Specific details

Type of Contract Full time
Preferred Education Bachelor's, Master's
Level of Experience 5-10 years

Location

Algeria, Africa
Algiers