ASSISTANT MANAGER - REGULATORY AFFAIRS

Job Location.
Gurgaon Overall purpose.
Regulatory and quality compliance for the entire Johnson & Johnson Medical franchise in India and IB Countries (SriLanka, Bangladesh, Maldives, Nepal & Bhutan).
To maintain the Life cycle management of the product registered by Johnson & Johnson.
Developed regulatory strategies along with internal stakeholders to coordinate and mitigate interdependencies of overlapping projects to successfully submit application to HA averting any business impact.
Ensures compliance with regulatory agency regulations and interpretations Essential duties and responsibilities.
Perform Regulatory impact analysis of the changes occurring at manufacturer level for product and production site & act accordingly ensure compliance with regulations through applicable submissions.
Organize and coordinate with the stakeholders to conduct training sessions and attended applicable training sessions.
Review and approve product labelling to ensure compliance with regulation.
Identify and develop RA staff by making accurate assessments of an individual's capabilities and performance, and providing feedback, coaching, guidance, and mentoring.
Participate and contributed in various technical committee of Medical device (MHD) conducted by Bureau of Indian Standard (BIS) and ensure compliance with standards.
Assisted in development of work instructions and SOPs to streamline the internal regulatory processes and ensure adherence to the same.
Pro-active communications with stakeholders to develop trust level, personal brand and keep them updated about the new regulation (if any).
Interface with cross-functional teams such as marketing, planning and Supply Chain to devise internal strategies for regulatory submissions.
Performed Regulatory impact analysis of the changes occurring at manufacturer level for product and production site & act accordingly ensure compliance with regulations through applicable submissions.
Create and submit other Regulatory submissions such as query responses, corrections filings, adverse/serious adverse event reporting and miscellaneous notifications regarding post registration changes to maintain regulatory life cycle of product for India, ASPAC, Sri Lanka and Bangladesh market in accordance with applicable regulations and guidelines Support with on-time inputs for monthly regulatory report.
Other assignment identified and assigned by Supervisor/ management- time to time Qualifications Requirements.
Strong knowledge of Medical Device Rule .
Strong knowledge of Medical device guideline for Sri Lanka, Bangladesh.
Knowledge in the international regulations of Medical Devices in US and EU.
Sound knowledge on Medical Device Quality Management System ISO .
Excellent proficiency with software tools.
Graduate/ Post Graduate in Life science/ Bio Medical/ Pharmacy.
Minimum 5-8 years Industry Experience in Regulatory Affairs, preferably in medical devices.
Sound understanding of MD regulations in India.
Experience of Submitting, Registering and maintaining Product registrations with MOH Experience in quality/ manufacturing and regulatory affairs in medical devices would be advantage.
Experience in assembling product dossiers for submission to Regulatory Authorities.
Good technical writing and communication skills.
Strong team leadership experience and motivational skills.
Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Core competencies required for this role.
Translate insights into innovative and viable products or solutions that create value.
Challenge the status quo; lead and adapt to change.
Take and properly manage risks.
Take ownership for and/or support talent acquisition, performance and development of self and others.
Leverage diverse perspectives, backgrounds and talent.
Engage in transparent and constructive conversations