Regulatory Affairs Supervisor / Manager
Implements locally the Group RA policy, strategy and objectives as defined by the Head of Global Regulatory Affairs
Manage the tasks for regulatory affairs, pharmacovigilance, promotional material review on regulatory perspective and support the quality assurance matters.
To give quarterly feedbacks & updates about Policies related to DCGI / CDSCO and other regulatory authorities in India & other territories.
Drive drug & medical device registrations and variations in accordance with relevant regulations and develop the strategy to obtain the product approval within target timeframe
Register and keep maintenance of production sites abroad.
Keep abreast of regulatory procedure and product changes to ensure products documents are maintained in compliance with local and corporate instruction.
Effectively communicate and collaborate with Regional / Corporate RA and Pharmaceuticals team in order to develop Regulatory Strategies & to provide local regulation intelligence to internal stakeholders
Maintenance of registration data base locally.
Maintain contact with the DCGI & CDSCO regulatory authorities & make regular official visits their offices to keep updated on the latest happenings.
Work along with the local Regulatory liaison agent for smooth execution & handover process.
Support the Regulatory prices related subjects in collaboration with commercial.
Be responsible for Pharmacovigilance including reporting / communication with HQ and authorities.
Implement Corporate SOPs, maintain local PV system and update local SOPs
Being a role of LRPPV (local responsible person of pharmacovigilance)
Ensure all PV related submissions are made & updated on time, in coordination with the HQ Team, Regional Team and in-country team.
Work along with the Deputy LRPPV.
Support the Implementation of corporate SOPs & local SOPs development on GDP and GDP certification & maintenance.
Handle quality related questions and complaints
Compliance and Administrative Duties
Ensure company’s products comply with the regulations
Plan and coordinate pack changes with related department
Validation of promotional material and packaging materials in compliant with local regulation and corporate policy
Required Skills & Background
Educations & Experiences
Pharmacist or related academic background is preferred
5-8 years of relevant experience in pharmaceutical drug registration
Experience in medical device registration, quality assurance or pharmacovigilance is favorable.
Skills & Qualifications
A good working knowledge of legal and regulatory issues
Proficient in MS Office, including Word, Excel and PowerPoint
Effective communication and interpersonal skills
Detail-oriented and independent team player
Excellent verbal and written communication skills in English and Hindi.
Work precisely according to procedures, rules and regulations
Recognize recurring issues and analyze their causes in order to reach a solution
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