Lactonova Nutripharm is Hiring for Asst Manager/Executive-Regulatory Affairs and has issued notification to accept Applications. Lactonova Nutripharm Inc. is an American multinational pharmaceutical corporation. Lactonova Nutripharm is one of the world’s largest pharmaceutical companies, and was ranked 64th on the 2020 Fortune 500 list of the largest U.S. corporations by total revenue, at $47.644 billion as of December 31, 2020 . Interested and eligible candidates required to fill application form in online with Education and personal details and submit application along with resume .Job application form link provided at the end of post. Eligibility for the Asst Manager/Executive-Regulatory Affairs as follows.
Vacancy summary details :
- Company Name: Lactonova Nutripharm
- Location : Hyderabad/Secunderabad( Mallapur )
- Post Name: Asst Manager/Executive-Regulatory Affairs
- Qualification: B.Pharm, M.Pharm B.Sc, M.Sc.
- Experience: 04 to 08 Years and B Pharmacy Freshers also.
- No of Vacancies: 02
- Details of Salary: 4,00,000 – 6,00,000 P.A.
- Closing date for online Application : Apply as soon as possible
- Date of examination: NA
- Time and Venue :NA
- Mode of application : online
- Selection Process: Shortlisted candidates may called for selection process (Â Personal interview , Group discussion , etc…,)
- Contact Number: Sathish Phone Number: 6303037351
Job Description/Skills Required:Â
An ISO Nutraceutical manufacturing company looking for Asst Manager/Executive-Regulatory Affairs. The candidate need to work in the plant which is located at I D A Mallapur, Uppal Mandal, Hyderabad 500 076.As a Manager- Regulatory Affairs with this fast growing, Nutraceutical manufacturing company, you will be responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labelling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues.
Specific Duties and Responsibilities:
- Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
- Timely compile materials for license renewals, updates and registrations
- Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
- Review labelling and labels for compliance with regulatory requirements
- Review changes to existing products and SOPs to define the requirements for regulatory submissions
- Provide the regulatory reviews of customer complaints and define the regulatory reportability
- Responsible for timely registration of the facility
- Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
- Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes
- Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
Core Job Responsibilities:
- Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
- Complete submissions to FDA, EU regulatory entities.
- Create and maintain product EU technical files.
- Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
- Supervise Regulatory Affairs consultants as required.
- Other duties as assigned
Requirements:
- Requires M. Pharm/B Pharm candidates
- At least 5 years relevant experience within the regulatory affairs discipline
- Knowledge of all Indian/US and international medical device regulatory requirements
- International experience is a plus
