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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Singapore, Singapore

Job Description:

SENIOR 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.g. focus on learning and development and ensuring a positive work environment in order to provide optimal support to business operations.

The position reports to the LOC Regulatory Affairs Lead.

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

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.

• Assume as RA Lead for assigned therapeutic areas to obtain 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, where applicable.

• Assist in the review of labelling and promotional materials

• Ensure post-approval commitments by the health authority are managed in a compliant manner

• Contribute in project management to develop strategies, prioritize assignments, coordinate and implement regulatory actions in accordance with strategic company objectives.

• 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.g. 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.

• Support coordination of product recall activities with commercial, supply chain and distributor which may be required by manufacturer or health authority.

• Assume role of SME/auditee for internal and external audits while supporting audit preparation

Consultation support

• Provide input and updates to the Head of RA 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.

Miscellaneous

• Support and contribute to Johnson & Johnson, Global and Asia Pacific Regulatory Affairs and LOC initiatives.

• Support other tasks or projects as and when requested.

QUALIFICATIONS, EXPERIENCE AND COMPETENCIES

Essential knowledge and skills:

• University degree in pharmacy, life sciences or equivalent field

• Minimally 2-3 years or more relevant work experience in Regulatory Affairs (RA) in the pharmaceutical industry

• Good technical RA knowledge relating to local regulations and international standards.

• Excellent verbal and written communication skills with proficiency in English

• Demonstrate strong analytical, organizational and problem-solving skills

• Must be able to develop and maintain collaborative working relationships, work successfully within a team environment and as an individual contributor

• Proactive team player, able to take charge and follow-through

• Independent, self-driven and change agent

• Coaching and mentoring of junior team members, where applicable

• Proficiency with Microsoft applications such as Excel, Word, PowerPoint. 

• A Singapore-registered pharmacist (Singapore Pharmacy Council) is preferred, but not mandatory for this role. Strong candidates without registration are encouraged to apply.

LOCATION

• This position is located in Singapore.

TRAVEL REQUIRED

• This role requires less than 10% of the time.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork