Assoc Dir, Regulatory Affairs

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X.  

Why join us?  

A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day. 

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. 

II. Key Responsibilities

Responsible for assuring products are cleared to market in the various countries in the region, plus assure compliance with local regulations and laws.

Development of short and long term regulatory strategies with the Regulatory Leadership and Commercial Teams

• Short term:
• Actively monitors regional market regulatory requirements, ensures communication of such regulatory requirements to the operating plants and continuously monitors the environment for regulatory changes
• Provides support for manufacturing plants to ensure that regulatory changes are addressed timely and efficiently.
• Product Registrations for the Region
• Compliance with FDA, Australian, European or other local regulation as appropriate
• Monitor and communicate to business and regulatory leaders changes or new regulations and standards development in the Region

• Long term:
• Active contribution as the Region RA representative to key strategic decisions impacting the development of regulatory compliance policies, processes and procedures
• Compliance with appropriate national regulations in the Region.
• Influence Region’s regulations and standards development
• Active participation in the Greater China ASR meetings to discuss recent developments and strategic plan for countries within Greater China.

Strengthen ties with Medical, Commercial, and Operational groups.

Active member of the Regulatory Leadership Team and active participation in development of functional policies, standards and strategy.

Provide interpretation of existing and emerging regulations and make recommendations for changes in quality systems, policies or procedures to a minimum standard set by RA Leadership.

Ensure that all facilities in the Region comply with the company’s regulatory requirements or relevant national requirements.

Establish and maintain divisional regulatory systems:

• MDR
• Registrations
• Licensing
• Label and promotional material approvals

Establish programs and policies for interface with all pertinent regulatory authorities in areas of:

• Government submission
• Regulatory letter responses

Provide training in key regulatory areas for the Region;

• New regulations
• Dealing with regulatory inspectors

Perform auditing of regulatory systems (as appropriate) for facilities in the Region.

Develop regional and in country Regulatory Affairs associates.

Build relationships between the company and any Government agency, which could affect the company’s products.

Translate regulatory strategy into guidelines for execution by site/region

Coordinate resources, capacity and systems requirements as necessary across region

Product modification/adaptation decision/promotional material, e.g., use of a local brand, packaging, etc.

Coordinate regulatory activities in the region

Perform any other tasks as assigned.

III. Education

Science Degree (Pharmacy/Biotechnology), Engineering Degree or equivalent

IV. Experiences

Minimum 8 years of experience in the following:

• Regulatory Affairs Systems
• Product licensing and registrations

VI. Required Knowledge and Skills

• U.S. FDA Quality System Regulations & Good Manufacturing Practices
• European Medical Device, IVD Directives
• ISO13485 Quality Systems
• Local regulations within the region
• Teamwork

• Listens effectively (actively listens)
• Include the RA Team in communications and activities where they must interact and cooperate
• Have regular conference calls to promote sharing and learning
• Promote inter-country assistance to leverage experience within the region
• Recognizes the interests and achievements of others
• Influencing Others

• Establish foundation of credibility based on integrity and past performance
• Be attentive to the different ways that others are persuaded
• Gain acceptance by understanding the viewpoints of others and seeking win/win solutions
• Ability to build relationships and influence with regulatory peers in the global businesses, other regions, other functions, and with country and region leadership

embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.