REGULATORY AFFAIRS SPECIALIST

Essential Job Duties and Responsibilities 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.
.
focus on learning and development and ensuring a positive work environment in order to provide optimal support to business operation.
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 CLRR.
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 post-approval activities required for a life cycle management submission.
Participate in team meetings, activities, and training 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 Departmental management 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.
New and existing products Responsible for effective product lifecycle management to ensure license maintenance and supply continuity.
Ensure product details in health authority system are up-to-date according to the relevant local and regional regulations.
Commercialise 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.
Contribute in obtaining new marketing authorization and expedite the availability of new drugs/indications to market.
Handle safety and quality issues related to products and develop regulatory strategies in line with local regulations to minimize supply continuity.
Partner with regional and global regulatory operations to prepare and submit all regulatory submissions independently.
Handle miscellaneous applications, such as ad-hoc permit and exemption request.
Contribute in project management to develop strategies, prioritize assignments, coordinate and implement regulatory actions in accordance with strategic company objectives.
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.
Compliance Responsible for overall compliance with regulatory requirements (e.
.
timely submission of dossiers, timely commercial implementation, timely implementation of new national and international legislation, etc) Maintain high level of awareness towards regulatory guidelines/directives/national requirements and identify business impact if any.
Contribute to developing strategies to close compliance gaps and execute action plans according to stipulated timelines.
Coordinate product recall activities with commercial, supply chain and distributor which may be required by manufacturer or health authority.
Consultation support Provide input and updates to the RA AM to facilitate discussions with other business functions.
Anticipate the impact of business decisions on regulatory and provides feedback to other business functions.
Participate in internal working groups as required and address any regulatory actions required from it.
Internal and external support Maintain close working relationship with regional and global regulatory operations.
Cultivate positive work environment with other functions within the LOC, including supply chain, quality, medical affairs, commercial, marketing, government affairs, legal, etc.
Support other functions based on their needs, e.
., tender, promotional materials, launch readiness, etc.
Foster and maintain professional relationship in any communication with the local health authority, in general and on product-specific topics.
Participate in industry-level regulatory events and maintain positive interactions with regulatory colleagues.
Miscellaneous Support and contribute to Johnson & Johnson, Global and Asia Pacific Regulatory Affairs and LOC initiatives.
Contribute to initiatives around lessons learnt and change management to ensure efficiency gains.
Support other tasks or projects as and when requested.
Qualifications Graduated with Bachelor's degree or equivalent in Science or related discipline.
A degree in Pharmacy and registered with the Pharmacy Board of Malaysia is an advantage.
1-2 years of experience in regulatory affairs at operational level in pharmaceutical industry is preferred, otherwise definite interest in RA position and skills development.
Direct experience and knowledge of general regulatory requirements and guidelines is an advantage.
Proficiency with Microsoft applications such as Excel, Word, Powerpoint and relevant IT systems.
Excellent verbal and written communication skills in English and Bahasa Melayu.