Avantor Chemistry Regulatory Manager Vacancy – Apply Online
Assistant Manager – Regulatory job opening announced by Avantor for chemistry candidates. BSc Chemistry job opening 2021. Avantor job opening 2021. Assistant Manager – Regulatory post vacancy 2021. Job opportunity for chemistry candidates. Check out all the details on the same below:
Job Title: Assistant Manager – Regulatory
Location: Mumbai, IND
Eligibility Criteria:
- Bachelor/Master’s degree in chemistry
- Experience with domestic and international regulatory filings and interactions with regulatory authorities required
Job Summary
Responsible for Review & preparation of dossiers, amendments, new applications for submission to regulatory authorities in India, responding to regulatory queries/issues from local authorities as well as Biopharma customers with minimum guidance, Direct Regulatory interaction with Indian Govt. authorities, biopharma customers, provide regulatory training to Biopharma customers with a good sense of maturity and Regulatory understanding that lead to major impact on our business growth in India. Provide Regulatory guidance to India management that has a significant impact on the strategy of new launches of various products including chemicals, excipients. Good knowledge and understanding of Indian regulations and regulatory issues/documents on excipients, Pharma chemicals, reagents, and Active Pharmaceutical Ingredients.
Skills & Experience Required:
- Good knowledge and understanding of India regulations, chemicals, excipients, Active Pharmaceutical ingredients with 6-8 years of relevant experience in regulatory and compliance matters in Pharma/life sciences/fine chemicals/excipients manufacturing companies
- High level of professionalism and maturity combined with the ability to interface the India leadership team within and outside the organization.
Ability to interpret India regulations and compliance documents - Intellectually curious and a willingness to adapt and learn about new areas of regulations.
- Able to work hard and deliver under pressure, establish priorities, and coordinate work
activities simultaneously. - Must be a team player with the ability to work independently.
- 4-6 years of relevant experience in regulatory affairs of excipients, chemicals, APIs.
Responsibilties:
- Review and submit registration applications in a timely manner and follow up through the application during the evaluation phase to achieve a favorable outcome.
- Provide Regulatory guidance to the India team that has a major impact on the strategy of new launches of various products including chemicals, excipients.
Filing NOC applications for dual-use Biopharma excipients and responding to the authority queries in a timely manner. - BIS registrations for Biopharma and Lab grade chemicals, excipients in India for timely registration and on-time approvals. Review and prepare the product registration as per BIS guidelines and other regulatory dossiers as per the requirement.
- Direct Interaction with Regulatory Agencies in India (BIS, CDSCO & Local FDA) and provide the required regulatory documents during the submission and approval process.
- Handling of regulatory queries/ issues with minimum guidance.
- Provide Regulatory training to management of Biopharma customers in India
- Review and submission of China registration of India-originated Biopharma excipients, APIs.
- Develop Regulatory SOPs and procedures.
- Evaluation of manufacturing and quality changes as per the regulatory guidelines and filing of variation, amendments and their implantation.
- Evaluation of specification of various products (chemicals, excipients) as per USP, EP, BP, IP, and BIS and their further implementation.
- Review of labeling as per requirements of Drugs & Cosmetic Act and Rules/ Legal Metrology Act.
- Regulatory Support during the Audits/ inspections from regulatory authorities in India
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