Work as Director in Regulatory Affairs at Johnson & Johnson
Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds. Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.
Post : Director - Regulatory Affairs
The Regulatory Affairs (RA) function is responsible for all facets of regulatory support to the Janssen business in India and IB countries (Sri Lanka, Bangladesh and Nepal). This role is part of the Janssen (India) Leadership Team (JLT) and besides the regulatory functional leadership role, this includes, being a Credo-based, collaborative inspirational leader who has follow-ship across the organisation. S/he is a talent champion driving inclusion and diversity. S/he also builds, contributes and drives the Janssen India strategy. As the functional leader of the RA function, this role ensures development of regulatory strategies, providing guidance, consultation for local regulations, interacting with government authority, participating in industry working groups, leading compliance initiatives, managing a team of regulatory professionals, managing regulatory projects and budgets. The primary expectation from this leader would be to accelerate new product launches/ Indications by crashing regulatory timelines. An understanding of Janssen products and their usage as well as an understanding of the regulations and their application is required.
• Overall responsible for regulatory deliverables from initial product registration to EOL for India/ IB countries. A critical expectation is to accelerate new product launches/ Indications by understanding 'work-arounds’ to crunch regulatory timelines
• Works closely with India, regional, and global teams to drive regulatory strategies and initiatives.
• Responsible for all acquired business integration and divestiture project completion as per defined strategy.
• Acts as advisor to team members to meet established schedules or resolve technical/operational problems.
• Prepares RA objectives.
• Submits and administers budget schedules and performance standards
• Plans and manages RA budget, resources, and projects. Responsible for oversight and prioritization of departmental tasks and projects. Directs and oversees the work of regulatory professionals, including training, mentoring, and professional development.
• Ensures people development through internal/external trainings or on-the-job learning.
• Responsible to represent the RA function in management reviews/meetings
• Ensures coordination with QA, Medical Affairs and other stakeholders in managing field action/ adverse event reporting to meet local country regulatory requirements.
• Ensures that the team members are healthcare compliant and Credo-based
• Ensuring review of promotional materials, as required, for regulatory compliance and acts as regulatory expert to develop teams.
• Interfaces and coordinates with regulatory agencies/competent authorities on submissions, approvals, audits or other issues.
• Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel/teams.
• Understands and influences local pharmaceuticals-related regulatory environment by leveraging key relationships with regulatory authorities and industry groups. Participates in working groups
• Interprets and applies local regulations to business practices and provides regulatory input, advice, and guidance to the organization.
• Responsible for regulatory compliance, which includes:
o Overseeing review of label preparation, including relevant internet activities to comply with all relevant internal policies/procedures and local country regulations.
o Coordinating with Business Quality/ Regional QA/Regulatory compliance leader on quality field actions and PMS.
• Sound knowledge of MOH set up, Drugs & Cosmetics Act & Rules, import license procedure.
• Good understanding of ICH regulations.
• Implement QMS systems, generate SOPs in the RA function and align the same with the Janssen quality system
• A Bachelor’s degree and above in Life Science/ Bio Medical/ Pharmacy
• Minimum 15- 20 years industry experience of RA in the pharmaceuticals industry.
• Leading a team of RA professionals.
• Experience in manufacturing knowledge in pharmaceuticals.
• Experience of submitting, registering and maintaining product registrations with local RA.
• Professional training as well as RAC certification will be an added advantage.
• Understanding of protocols, clinical reports, and dossier preparation.
• Experience in assembling product dossiers for submission to RA.
• Sound understanding of ICH regulations
• Good technical writing and communication skills
Experience : 5+ Years
Qualification : B.Sc, B.Pharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th October, 2019
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