Job Description

Our client is an established medical device MNC and they are looking for a Regulatory Affairs Manager to join them in overseeing the APAC region. As their Regulatory Affairs Manager, you will perform regulatory activities and be responsible for managing product registrations and submissions for product lines and / or geographical areas. Additionally, you will support activities related to the launch of new products and maintenance of existing products whilst maintaining regulatory compliance and regulatory systems for the Company.

Responsibilities

• Provides technical guidance and regulatory training/mentoring to other Regulatory Associates and/or cross functional teams
• Create new methods, techniques and/or processes across job areas or functions exerting some influence on the overall objectives and long-range goals
• Manages functional group’s product compliance, change management, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives
• Responsible for overseeing regulatory compliance, development and timely national regulatory submissions, ensuring that all regulatory activities are conducted with the highest integrity and in an ethical manner
• Reviews staff submissions to identify adequacy of sections, completeness and consistency of story and overall content of submissions, may be responsible for authoring submissions when needed
• Interprets, executes, and recommends modifications to operating policies at business level. Will establish operating policies within specific business operating area and recommend policies that impact other areas.
• Communicates regulatory strategy effectively to all departments, senior management, regulators, and regulatory agencies to achieve timelines
• Ensures that all outside official communications comply with the appropriate regulations and internally approved regulatory and marketing claims
• Reviews and prepares for Post-market regulatory actions to national authorities as and when required
• Acts a leader who embodies regulatory expertise as well as business acumen with a positive corporate mindset

Requirements

• Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered
• Minimum 8 years’ experience in Regulatory Affairs
• Direct experience in approvals for devices in APAC
• Experience in an environment where skills in negotiation, listening, persuasion, collaboration, compromise and analytic based judgement is used daily
• Demonstrated success in the management of regulatory submissions in APAC
• Knowledge of technical aspects of regulatory profession, combined with scientific understanding and project management skills
• Understands how product approval strategies interact with business strategies. Identifies regulatory and clinical challenges and ability to resolve them through collaboration
• Recognized as an emerging authority within the business or function with broad understanding of and experience working with multiple functions that are unrelated
• Able to manage ambiguity and have ability to fill gaps with alternative data
• Expert with Regulatory issues involving multiple product lines, or geographies, or specific business processes and procedures
• Possess business insight and have ability to understand how product approval strategy interacts with business strategy, may involve in creating/ proposing such strategy
• Nimble learning and able to actively seek out relevant legislation and competitive information on product lines
• Must be results oriented and decisive. Failure to obtain results or arrive at appropriate decisions in a timely fashion could impact compliance risk or cause delays in planned product launch.
• Demonstrated analytical and creative thinking skills and the ability to solve complex problems
• Able to mentor and develop talent of direct reports
• Ability to interact with diplomacy and tact while maintaining appropriate assertiveness
• Willingness to take ownership and accept responsibility, ensuring accountability for actions and decisions
• Must be detail oriented, well organized and able to work both independently and in teams
• Knowledge and use of relevant PC software applications and skills to use them effectively
• Demonstrated ability to communicate effectively both verbally and in writing
• Regulatory Affairs Certification (RAC) desired or an equivalent competency level acquired through a variation of these qualifications may be considered.
• Some travel may be required (15-20%).

We thank you for your interest and we regret that only shortlisted candidates will be notified. All resumes received will be used for recruitment purposes only. EA License No.: 11C3242 Reg No.: R1103318