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MSN Laboratories is urgently hiring for a position in Regulatory Affairs within their Formulation Department.
- Regulatory Affairs – Assistant Manager/ Dy. Manager / Manager/ Senior Manager 8-20 yrs
Qualification: B. Pharm / M. Pharm
Formulation Regulatory Affairs US, Canada, Australia, China, Europe, CIS, Latam, Asia, Africa, ROW Market
Job responsibilities:
- Accountable for compiling, reviewing and submitting regulatory submissions together with their amendments to USFDA.
- Lead CMC team to ensure highly qualified personnel that is able to perform to meet company ANDA filing requirements.
- Well versed in review and clearance of Technology transfer documents (Specs, MFR, IID, stability protocols, BMR, additional study protocols etc) related to ANDA submission from cross discipline teams.
- Placing the USFDA ANDA filing requirements to cross discipline teams timely and ensuring the same in ANDA submission.
- Good knowledge in CMC/SBOA/other agencies CMC evaluations and provide inputs for ANDA submission.
- Preparing Regulatory submission strategy sheets with all ANDA filing requirements and make the teams understand and align during product initiation.
- Providing quality inputs for CMC teams during compilations to ensure minimal queries during ANDA assessment cycle.
- High quality review of RTR points during development activities and ANDA submission.
- Represent CMC regulatory view point and expertise on the US ANDA CMC team, including regulatory risk assessments and mitigations with proposed strategies.
10. Preparation of controlled correspondences required during product development and submission.
11. Review all regulatory agency submission documents to ensure timeliness, accuracy, comprehensiveness, or compliance with USFDA standards.
12. Develop regulatory strategies and implementation plans for the preparation and submission of new products.
13. Good knowledge about important developments in FDA and evaluate product development requirements to meet the same.
14. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
15. Participate in decision making process with other applicable departments.
16. Review and approve all change controls from manufacturing sites, when required.
17. Good written and verbal communication skills in liaising with cross discipline teams.
Interested and relevant candidate share updated profiles along with current CTC, expected CTC and notice period. Please apply only if your profile is matching the above requirements to
narasimharaju.manthena@msnlabs.com
