Regulatory Affairs Specialist

2 weeks ago

Subang Jaya, Selangor, Malaysia Johnson & Johnson Full time

Position Summary

  • The Regulatory Submissions Professional is a member of the Local Operating Company Regulatory Affairs team and
is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life cycle management submissions are under the scope of the Regulatory Management Centre
(RMC), and this Submissions Professional is responsible for exclusively managing RMC submissions, whilst being
part of the overall regulatory team in the LOC.

  • This is a hybrid role which is also responsible for regulatory activities to support LOC and grow the business in line
with the company goals. This role is also expected to adhere to Johnson & Johnson core values, e.g. focus on
learning and development and ensuring a positive work environment in order to provide optimal support to business
operation.

Key Responsibilities:

RMC

  • Receive CLCN and CMC variations from the AP RMC and identify if submission to the local Health
Authority is required.

  • Assess dossier for impact to country registration.
  • Provide details on submission strategy to the AP RMC to ensure timely updating of compliance tracking
systems.

  • Prepare submission dossier based on global dispatch and country specific requirements.
  • Request country specific documents for submission, such as data administration, translation, artwork,
samples and certificate.

  • Work with the RMC Liaison who will be the single point of contact with global teams, to resolve any issues
with the submission package from global.

  • Ensure country specific requirements are accurately maintained in RIACS.
  • Receive HA queries and send to the RMC Liaison assigned to the product portfolio for management.
  • Communicate submission and approval dates of life cycle management submissions to the RMC Liaison.
  • Complete any postapproval activities required for a life cycle management submission.
  • Participate in team meetings, activities, and trainings as a full member of the LOC regulatory affairs team.
  • Communicate local regulation changes in a timely manner to the RMC Liaison who has been assigned as
the country/cluster partner.

LOC

  • Handling incoming and outgoing correspondence including archiving of important communication.
  • Maintain the local product files in line with current registered authorization details.
  • Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
  • Ensure product details in health authority system are uptodate according to the relevant local and regional
regulations.

  • Commercialize and maintain product packaging and labels in line with current registered details.
  • Identify potential risks and provide resolution to production and manufacturing issues, such as
submission/negotiation strategy, sourcing interest, packaging issues, and compliance matters.

  • Process champion for DD & PSY quota, import/export permits, product list, LIFT compliance record and
document control.

  • Ensure deadlines for different projects are met or escalated to Regulatory manager and/or Head of RA.
  • Maintain the product label and packaging in line with current registered authorization details according to
the relevant local and regional legislation

  • Contribute to compliance with all regulatory requirements (e.g. timely submission of dossiers, timely
implementation of new national and international legislation, timely implementation and training of SOP's &
supporting systems)

  • Maintain an awareness of regulatory guidelines/directives/national requirements.
  • Support other departments based on their needs (logistic, quality, pricing, medical, marketing, sales).
  • Support other functions based on their needs, e.g. tender, promotional materials, launch readiness, etc.
  • Ensure positive interaction in any communication with the local health authority, in general and on product specific
topics.

Qualifications:

  • University degree in pharmacy, life sciences or equivalent field.
  • 3 years or more relevant work experience in Regulatory Affairs/Government Affairs/Quality/Compliance/
Manufacturing in medical or pharmaceutical companies.

  • Experience of working in a virtual team and/or global organization.
  • Previous experience in RA role as Associate, Professional or similar role is of advantage.
  • Knowledge of local regulations and international standards.
  • Able to make independent decisions.
  • Able to analyze (complex) information and situations and to formulate clear solutions.
  • Constructive team player.
  • Good communication and collaboration required.
  • Project management: build and lead project teams, get things done, drive execution, collaborate in virtual
teams.

  • Strong interpersonal and communication skills.
  • Ability to manage multiple tasks and projects simultaneously.
  • Detailorientation combined with being able to take a step back (helicopter view).
  • Analytical skills and technical RA knowledge (ability to assess impact of CMC variation or Label change on
c

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