Regulatory Affairs Director

2 semanas atrás

São Paulo, São Paulo, Brasil Amgen Tempo inteiro

HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Local Regulatory Representative (LRR), Director Brazil, Argentina and Colombia**:

The Local Regulatory Representative (Director) is assigned to one or more Amgen products, and leads the planning and execution of the Regulatory strategies for that product(s) in their country(ies).

The product(s) assigned have high complexity programs/strategies and high impact to Amgen.

The focus in on Brazil in terms of managing the regulatory team and the submissions, while Local Regulatory Representative Heads dedicated to Colombia and Argentina are in place and need to be overseen.

  • Assist in aligning local regulatory requirements with Amgen's corporate standards.
  • Provide local input to and complete regulatory strategies.
  • Plan and handle local regulatory submissions in compliance with corporate standards and local regulatory requirements.
  • Provide guidance on local mechanisms to optimize product development and regulatory approvals
  • Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
  • Ensure and support local regulatory product compliance
  • Act as the point of contact with regulatory agencies for BR.

Key Activities:

  • Gives for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local crossfunctional team.
  • With mínimal supervision, implements 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 leads 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 nonpromotional materials.
  • Monitors changes in the local Trade Associations /national legislation and forwards information to local/regional groups presenting 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).
  • Leads the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.

Health Authority Interactions:

  • Acts as the point of contact with BR regulatory agencies in fulfilling local obligations.
  • Participates to local agency interactions and their preparation.

Communication and Collaboration:

  • Works closely with crossfunctional colleagues in the country, Affiliate or Hub to align on strategy and deliver country/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 International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) 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 on specific product assignment (if applicable).
  • Establishes regular contacts and interactions with Distributors (if applicable).
  • Provide SME support to process improvement projects
    /initiatives.

Country Specific Activities:

  • Assists locally in Healthcare Compliance activities where applicable.
  • Participates in local regulatory process improvements, initiatives, and training.
  • Leads all aspects of external vendor/contractor relationships where applicable.

Regulatory Research:

  • Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products
  • Performs regulatory research to obtain relevant histories, precedence, and other information relevant to regional product advancement

Mentoring:

  • Mentors and/or advises other(s) Local Regulatory Representatives at more junior levels.

Knowledge and Skills:

  • Knowledge of Regulatory principles.
  • Working with policies, procedures, and SOP's.
  • Comprehensive understanding of regulatory activities and how they have an effect on other projects and/or proce

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