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Head Regulatory Affairs and Quality Assurance
- Head Quality Assurance and Regulatory Affairs for a leading MNC
- Be a part of the Leadership Team
About Our Client
Our client is an European MNC, specialising in consumer healthcare and medical devices. They are present across 20+ countries globally and for their India operations, they are looking to hire their Head of Regulatory Affairs and Quality Assurance, based out of Chennai.
Reporting to the Regional Head - RA/QA your roles and responsibilities would include :
- To lead in new products registration and license renewal compliance to local regulations, as well as GMP, GDP and ISO requirement.
- To lead the QA/RA team and ensure quality and good standard operating procedures within the company.
- Have the overall responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment.
- Oversee the maintenance of product quality and compliance through the Quality Assurance and Quality Control functions as well as management of the Quality Management System and compliance processes.
- Provide training on policies and procedures, regulations and guidelines, both existing and emerging.
- Support Commercial Department in business development such as product evaluation and pre-launch activities.
- Keep abreast of international legislation and guidelines of current product line in India.
- Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements.
- Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements
- Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production & QA team to provide advice on process and labeling changes.
- Review of SOPs, BPRs, specifications and change control to ensure compliance.
- Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
- Drives resolution of issues. Communicates issues, impact and outcomes to the management team.
- Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.
- Responsible for ensuring compliance to the submission standards, procedures and policies in India.
The Successful Applicant
- 10+ years of experience in regulatory affairs and quality assurance in the healthcare industry
- Bachelors degree in relevant field.
- Experience in leading a team with few years of management responsibility.
- Demonstrate strategic thinking and business acumen - applies organisational understanding and awareness in decision making.
- Ethical behaviour and high level of integrity.
- Good team work, independent and committed to works across functional departments
- Possess good negotiation and dispute resolution skills.
- Demonstrated experience operating in a regulated environment.
- Demonstrated knowledge of regulatory issues, and experience interfacing with local regulatory bodies.
- Ability to read, analyse, and interpret governmental regulations and reports.
- Ability to write reports, business correspondence, and quality procedures.
- Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities.
What's on Offer
An opportunity to head RA & QA for a rapidly growing Health care MNC, along with market leading compensation.