Job title: years Contract – Regulatory Affairs Manager
Company: Amgen
Job description: Career Category Regulatory
Job Description
The Local Regulatory Representative (Sr. Associate / Manager) is assigned to one or more Amgen products, and plans and executes the Regulatory strategies for that product(s) in their country(ies). The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.
Assist in aligning local regulatory requirements with Amgen’s corporate standards.
Provide local input to and execute regulatory strategies.
Plan and manage 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 (eg, IMR, PMCs, and agency commitments)
Act as the point of contact with regulatory agencies.
Strategic and Execution
Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
With close 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).
Manages the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed.
The LRR is also responsible for:
Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Strategic Plans, labeling documents, etc.
HEALTH AUTHORITY INTERACTIONS
Acts as the point of contact with regulatory agencies in fulfilling local obligations.
Participates/contributes to local agency interactions and their preparation.
COMMUNICATION AND COLLABORATION
Works closely with cross-functional 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.
Oversees external vendor/contractor relationships where applicable.
Assists locally in Healthcare Compliance, QA or pharmacovigilance activities 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
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
Ability to understand and communicate scientific/clinical information.
Demonstrate strong teamwork ability and able to execute role independently
Good communication skills – both oral and written.
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
Good negotiation and Influencing skills.
Education & Experience (Basic)
Master’s degree (scientific area) / Bachelor’s degree (scientific area) and 4 years of directly related experience
Education & Experience (Preferred)
Good understanding of D&C Act and Rules, Registration and Import of New Biological, Chemical Entities, Clinical Trials, Biosimilars
Execute submissions via SUGAM
Can execute Post approval submissions for clinical trial maintenance
Familiar with Regulatory maintenance activities: Labelling updates, CMC variations, Renewals
Understanding of working practices at Indian Regulatory Agencies
.
Expected salary:
Location: Mumbai, Maharashtra
Job date: Sun, 01 May 2022 06:18:59 GMT
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