Amea Quality and Regulatory Leader

**The**Opportunity**:
Responsible for all day to day management of Quality and regulatory affairs of the organization in AMEA. Communicates with senior leadership of AMEA regarding regulatory and quality matters of strategic importance. This position is accountable for providing direction in the cGMP (API, excipient, MedDev) and/or non-GMP (Lab and industrial chemicals) manufacturing & distribution environment to produce safe, compliant and quality products and/or services in biopharma, healthcare, education, and advanced technology and applied materials industries.
Responsible for product compliance with applicable regulations and approvals from local regulatory authorities in order to achieve the business targets with regulatory prudence and compliance. Focus on tactical and operational plans with short-term focus. Serve as the evaluator and key decision
- maker of all issues and concerns related to Quality and regulatory obligations for the organization in AMEA region.

The role scope includes Regulatory operations, Quality System (QS), Quality Assurance (QA) and Quality Control (QC) programs at the sites to ensure compliance with the applicable requirements.

In this leadership role, the individual is responsible for promoting a culture of quality, compliance and continuous improvement. This role will ensure associate safety, engagement, and development. Establish and implement strategic plans and initiatives to improve quality, delivery, inventory and productivity via ABS (such as six sigma, lean etc). And make significant decisions that will impact regulatory compliance, customer satisfaction, associate engagement and financial performance.
What are we looking for:

- Bachelor/Master’s degree in chemistry, biochemistry, Pharmacy.
- Demonstrated experience in a leadership role overseeing quality or Regulatory operations across multiple sites or regions.
- Experience with domestic and international regulatory filings and interactions with regulatory authorities required.
- 15+ years of applicable work experience in a combination of Quality and Regulatory roles in a regulated cGMP manufacturing environment. Preferred cGMP API and excipient chemical manufacturing experience.
- Experience in coaching, mentoring and developing others.
- Demonstrated understanding of Regulatory Affairs processes, both pre
- and post-marketing is required.

How you would make the impact:

- As part of the Avantor’s Quality and Regulatory Operations leadership team, lead the site Quality and Regulatory teams to establish, and achieve, a vision, strategic plans, initiatives, and annual/corporate objectives.
- Develop and cultivate high performing Quality, Regulatory teams, Management Systems, and cross-functional partnerships.
- Provide quality and regulatory support & management to the organization in AMEA by coordinating with the existing quality & regulatory professionals in the region. Act as the first point of contact for Senior and Executive leadership of AMEA as well as Drug regulatory authorities for any regulatory or compliance requirements in the region.
- Provide strategy, guidance and supervise the product registrations including ChP registrations of Excipients, manufacturing & drug product licenses and approvals, new product launches, life cycle management of products including renewals, annuals updates, amendments, import/exports licenses across sub regions of AMEA i.e. Middle East Africa, India, South East Asia, China, Korea, Japan & Australia.
- Interfaces with regional leaders of other functions in AMEA to advise them of the regulatory requirements and the changes and/or addition of business they propose to undertake. Analyzes the impact of these changes including regulatory compliance, customer satisfaction and Avantor profitability to the extent these parameters are tied to full regulatory compliance.
- Support the functions like trade compliance, product storage, labeling and packaging, product information management, supplier & customer screening, among others.
- Ensure sites are driving continuous improvement, via the QMS and ABS, to achieve Quality compliance, performance targets, and business objectives.
- Provide leadership, guidance, and expertise on quality matters, to include product field actions and complaints, external audit compliance and compliance requirements.
- Proactively communicate with top management, customers, regulatory agencies (CDSCO, HSA, NMPA, PSB, KReach, SFDA, MOH etc.) and internal stakeholders on Regulatory and Quality strategy plans and annual objective progress, regulatory changes, product performance, and improvement initiatives.
- To oversees quality operations across multiple manufacturing and distribution sites in the Asia-Pacific (APAC) & IMEA regions, playing a crucial role in driving operational excellence, enhancing product quality, and supporting business growth initiatives within the regional context.
- To support new product introduction and oversee the supplier qu