Specialist - Regulatory Affairs - Pharma

About the job:

Job Profile for 4-8 experience in RA (Sterile application filings) (Senior Executive to Asst. Manager):

- vHands on exp in Regulatory Affairs-US Market for Parenteral dosage forms. Review/assessment of documents for regulatory compliance like Drug master files, Specifications, standard test procedures and validation documents of Parenteral dosage forms.

- Co-ordinating with mfg. facilities to build sterility assurance package for Parenteral applications.

- Co-ordination with various sites/teams (viz. development site, manufacturing site, contract testing sites and DMF holder) for collection and review of documents related to ANDA, deficiencies and post approval supplements.

- Review of Master formula cards, Pharmaceutical Development Report, stability and process validation protocols.

- Reviewing BMRs, PBRs and validation reports for appropriateness.

- Preparation, review and compilation of Original ANDA submissions for US market in eCTD format for Parenteral dosage forms.

- Preparation and review of response to Agency's queries and submission within the stipulated time given by USFDA.

- Preparation and preliminary review of draft labels, final labeling artwork, SPL and package inserts.

- Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.

- Review, compilation of Annual reports and post approval changes such as CBE, CBE 30 and PAS (Prior Approval supplements).

- Keeping abreast of US legislations, guidelines and customer practices.

- Maintenance of work tracker for all projects from initiation to the final completion state