Regulatory Affairs Manager
Contract Duration of 3-4 months
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Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.
Company Description:
Our client is an MNC Healthcare company. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, they are empowered to tackle the world's toughest health challenges, innovate through science and technology, and transform patient care.
Summary:
The Manager, Regulatory Affairs is responsible for all aspects of regulatory responsibilities in Singapore and Malaysia.
Critical to this role is to combine knowledge of scientific, regulatory, and business issues to enable all products that are developed, manufactured or distributed to meet all the required legislations in the applicable markets.
Additionally, this role is responsible for directing and supporting regulatory related matters such as registration of new products, change management, renewals, claims, advertisement and promotional materials review, labelling support, and external environment surveillance.
This role has market & business level influence and responsibility, and is considered a key opinion leader and an expert resource externally on all regulatory matters in the applicable markets.
This Manager will be actively called upon to influence changing regulations and guidance, interface with external regulatory agencies and trade associations and to provide executive management with regulatory metrics/information. Adheres to company policies, procedures, and supports department objectives.
Main areas of responsibility:
- Responsible for Singapore and Malaysia.
- Direct and support regulatory related matters such as growth & innovation and post-marketing Lifecycle Management (LCM) regulatory activities e.g., new product registrations, change management, renewals, claims, advertisement and promotional materials review, labelling support, and external environment surveillance.
- Oversee creation of global regulatory product development strategies and preparation & submission of marketing approval applications to health authorities to ensure that development plans meet global regulatory requirements.
- Ensure compliance with product post-marketing approval requirements.
- Develop and advance the organization's policies and procedures related to regulatory affairs and compliance to foster a culture of adherence and regulatory integrity.
- Interact with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business. Participate in applicable external trade association or industry working groups to influence policy in alignment with business strategies.
- Identify and address risks and business requirements. Ensure the development and implementation of leading-edge systems and best practices both internally and across sites or company-wide. Identify and implement new regulatory policies, processes and SOPs, as appropriate.
- Provide project leadership or participate as a team member on major initiatives that have high impact to the business. Apply influence across departments and the business.
- Support coordination and back up coordinator to ensure smooth operation and effective use of the Veeva system within the organization (a copy clearance approval for advertisement and promotional material, and local labelling.
- Responsible for managing and coordinating various aspects of the Veeva system to support sales, marketing, Prof Ed and regulatory activities, and ensure compliance with the applicable copy approval procedures.
- Support regulatory projects e.g., advertisement & promotional materials & process audit, copy review process simplification.
Other duties:
- Determine and communicate submission and approval requirements. Communicate application progress to internal stakeholders.
- Compile, prepare, review and submit regulatory documents for product approval and registration with health authorities.
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies and complete all regulatory projects as assigned.
- Maintain up-to-date knowledge of regulatory requirements across different markets. Monitor and assess the impact of changing regulations on submission strategies.
- Manage product labelling in line with local regulatory guidelines.
- Review and approve advertisement and promotional materials to ensure compliance with local regulations and requirements.
- Assess acceptability of documentation for submission filing to comply with regulatory requirements for marketing applications, clinical trials and corporate goals, to secure submission approvals.
- Participate in new product development by offering insights and expertise on regulatory requirements, assessing global regulatory strategies, and recommending future strategies and actions.
- Coordinate with external trade association or industry working groups on regulatory
Requirements
- Minimum Degree in any Science course with minimum 5 years of experience
- Proven experience in regulatory affairs within the pharmaceutical or medical device industry. (Medical device related industry experience is preferred.)
- Strong understanding of regulatory requirements and submission processes in the specified markets.
- Expert knowledge, understanding and application of principles, concepts and practices of government regulations.
- Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.
- Ability to organize and analyze technical data and identify issues or gaps.
- Ability to work cross-functionally and manage multiple projects.
- Excellent organizational and negotiation skills. Ability to effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met
Interested parties, please apply through this link https://jnj-apac.talent-pool.com/projects OR click on APPLY button.
Alternatively, you can share your CV at [Confidential Information]
EA License: 94C3609
Reg No: R1440247
