Regulatory Affairs for US based Pharma company

Key Responsibilities:-

- Plays a pivotal role in continually improving working relationships within and across departments in relation to department and company goals and objectives with regards to FDA submissions.

- Leads ANDA compilations and submissions for sterile and semi-solid dosage forms.

- Reviews all regulatory submissions, including ANDAs, amendments, supplements etc., for following dosage forms to ensure high quality submissions with an overall objective to receive approval within the shortest time frames possible: topical ointments, creams, gels, solid orals (tablets & capsules), liquid orals (suspension and solutions), nasal spray solutions.

- Interacts with Product Development, Analytical Development, QA/QC, Operations, and purchase teams as needed to provide guidance with respect to regulatory issues and to get support from them for the regulatory team.

- Maintains current knowledge of regulations and other issues that affect products and industry.

- Monitors status of ANDAs, controlled correspondence and supplements submitted with USFDA.

- Follows up with FDA when necessary to obtain the status of these submissions.

Education/Technical Skills:-

- Master Degree (MS/MA) Pharmacy or related field - Preferred.

- Required Experience: 4-10 years of experience in Regulatory Affairs - for sterile and semi-solid dosage forms (nasals, injectables, ointments).

- Must have knowledge of ANDAs, ICH and FDA regulations, product dosage forms, 21 CFR and cGMPs.

- Ability to use MS Office

Key Attributes:

- Proactive and results oriented with a positive attitude

- Good interpersonal skills with strong ability to collaborate effectively with individuals at all levels of organization

- Detailed oriented with work of highest quality

- Proven ability to work under pressure with tight deadlines to achieve corporate goals

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