Quality & Regulatory Affairs

Quality and Regulatory Affairs

Excellence in Quality for Life Science Quality and Regulatory Affairs

Arka Innovate is a trusted recruitment leader in the Life Science industry, specializing in connecting top talent with critical roles in Quality and Regulatory Affairs for both Pharmaceutical and Biotech sectors. We understand that maintaining quality standards and navigating the complex regulatory landscape is crucial for bringing life-saving products to market. Whether you’re seeking contract or full-time hires, Arka Innovate provides the right talent to ensure compliance, safety, and success.

Capabilities in Life Science Quality and Regulatory

In the pharmaceutical industry, stringent regulatory requirements and quality standards are key to ensuring patient safety and product efficacy. Arka Innovate delivers skilled professionals who understand the nuances of these areas, including but not limited to:

Quality Assurance (QA) Managers and Directors
Regulatory Affairs Specialists
Quality Control (QC) Analysts
Validation Engineers
Quality Systems Managers
Validation Scientists

Why Arka Innovate?

Arka Innovate is committed to delivering strategic talent solutions in Quality and Regulatory Affairs, enabling pharmaceutical and biotech companies to meet the highest standards of compliance, safety, and efficacy, while ensuring smooth product approvals and successful market entries.

Tailored Recruitment

Regulatory Expertise

Global Talent Network

Quality Assurance (QA) Managers and Directors

who lead GMP compliance, internal audits, and quality management systems (QMS) to meet regulatory expectations

Regulatory Affairs Specialists

experienced in submissions for new drug applications (NDAs), biologics licence applications (BLAs), and handling FDA and EMA regulatory interactions

Quality Control (QC) Analysts

and Microbiologists responsible for analytical testing, ensuring pharmaceutical products meet required quality specifications and safety profiles

Validation Engineers

ensuring that processes, equipment, and systems are fully validated in compliance with ICH guidelines, ensuring robust product manufacturing and consistency

Regulatory Compliance Experts

who manage global regulatory submissions, handle product lifecycle management, and maintain compliance with evolving regulatory requirements

Capabilities in Biotech Quality and Regulatory

Biotech companies operate in a highly regulated environment where innovation must be balanced with strict adherence to quality and regulatory guidelines. Arka Innovate identifies and places top professionals in roles such as:

Regulatory Affairs Managers

with deep expertise in biologics, gene therapy, and advanced therapies who lead interactions with regulatory bodies, ensuring IND, CTA, and post-market compliance

Quality Systems Managers

who oversee the implementation and continuous improvement of QMS, ensuring alignment with ISO standards, ICH guidelines, and industry best practices

Validation Scientists

specialized in bioprocess validation, ensuring that manufacturing processes for biologics and biosimilars meet both quality and regulatory expectations

Regulatory Strategy Leads

who guide biotech companies through complex regulatory pathways, including orphan drug designation, breakthrough therapy applications, and accelerated approval processes

Quality Auditors and Regulatory Compliance Specialists

who conduct internal audits and ensure readiness for FDA inspections, EMA audits, and GxP compliance across global markets