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29/06 HR
HR at Michael Page

Views:1800 Applications:21 Rec. Actions:Recruiter Actions:0

Head - Regulatory Affairs & Quality Assurance - Pharmaceuticals (8-15 yrs)

Chennai Job Code: 350873

Industry : Pharmaceuticals

Skills : Regulatory Affairs, Quality Assurance

Job Type : Permanent

Description :

- Responsible to improve and implement the QMS for ISO 9001:2008 and ISO 13485:2003, European Medical Device Directive MDD 93/42/EEC

- Follow-up the Indian GMP regulation and ensure compliance of the technical file according to Indian regulation.

- Responsible for monitoring of critical processes for site in compliance of operations, Quality Management and regulatory affairs.

- Point of contact between the responsible countries, HQ and Asia regional office in ensuring processes and local activities meet the respective country's regulatory and legal requirements.

- Management Representative for the company. To be involved in Management review committee and an Executive Board member.

Client Details :

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.

Job Description :

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.

Profile :

- 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.

Job Offer :

- An opportunity to head RA & QA for a rapidly growing Health care MNC, along with market leading compensation.

Page Group India is acting as an Employment Agency in relation to this vacancy.

Contact : Nupur Mehta

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Women-friendly workplace:

Maternity and Paternity Benefits

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