Amneal Pharmaceuticals→

Deputy Manager, Regulatory Affairs at Amneal… · Gujarat

Mid LevelOn-siteFull-timeGujarat, Gujarat, IN

Skills

regulatory affairsinjectable dosage formanda submissiondeficiency responses505(b)(2) productsus fda regulationseu regulationsdmf reviewpre-anda/pre-ind/sca meeting packagescomplex product strategycritical thinkingprocess orientationperformance orientationprioritizationjudgmentintegritycompliance mindsetownershipaccountabilitycollaborationteam-oriented approachcross-functional collaborationexperience with us fda meeting packages

Job Description

Candidate with Master's degree in Pharmacy, minimum 8-10 years experience in regulatory affairs injectable dosage form, hands on experience in submission of ANDA and deficiency responses for US market. Additionally candidates with experience in submission of meeting packages to US FDA is preferred.

Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.
Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
Draft and finalize controlled correspondences on complex issues.
Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products.
Review API and FP in-vitro characterization/sameness reports.
DMF review for complex APIs as per the workflow.
To collaborate and work closely with cross functional teams.
To meet the management expectations w.r.t timelines and quality.
To work closely within the team and provide training to new members on new regulatory requirements for Complex products.

Qualifications

Suitably qualified individuals with strong Scientific and Regulatory background.
Academic degree in Pharmacy (M. Pharm or PhD), with preferably specialization in Regulatory Affairs or Pharmaceutics.
Experienced (minimum 8-10 years) in Regulatory Affairs with Injectable dosage form and overall experience 12+ years.
End to end complete understanding of Complex Products for US/ EU market right from Strategy, Filing, Deficiency response etc.
Experienced in drafting controlled correspondences, Meeting packages etc.
Experience being an active contributor to cross-functional teams and/or working in matrix organizations. High quality, critical thinking, process, and performance orientated; prioritizes activities and projects.
Exercises good judgment on regulatory, quality, and technical related compliance issues. High personal integrity; trustworthy; strong compliance and quality mind-set.
Solution orientated, strong sense of ownership and accountability.
Collaborative, team-oriented approach, capable of working cross-functionally, and in a matrixed and integrated way.

About the Company

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.