Senior Manager Regulatory Affairs

Advagenpharma; Windsor; On-site; USD 100,000 - 175,000; Full time

Job summary

Advagenpharma is seeking a Regulatory Affairs Manager to oversee regulatory communications for US filings and manage relations with the USFDA. This mid-senior level position requires 10-15 years of experience and proficiency in regulatory affairs, along with excellent communication and analytical skills.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Proficiency in Regulatory Affairs.
• Prior work experience with USFDA is preferred.
• Excellent communication, analytical and planning skills.

Responsibilities

• Manage regulatory communications for US filings.
• Prepare regulatory strategies for global filings.
• Coordinate regulatory submissions for specialty / 505b2 projects.

Skills

Communication

Planning

Analytical Skills

Interpersonal Skills

Job description

1 week ago Be among the first 25 applicants

Direct message the job poster from AdvaGen Pharma

Human Resources & Talent Acquisition at Rubicon Research I AdvaGen Pharma I Validus Pharma

About Our Parent Company Rubicon Research

Rubicon Research is an IP led, specialty pharmaceutical company focused on a mission to provide

innovative yet affordable patient-centered products and solutions to address unmet needs around the world. We leverage our proprietary technologies and specialized formulation development skills to provide solutions to complex delivery challenges, enabling better patient outcomes.

• Our portfolio spans multiple dosage forms, including oral solids, oral liquids, nasal, ophthalmic, injectable, topical, drug device combinations and fixed-dose combinations.
• We hold more than 50 issued patents in drug delivery technologies, and have launched over 200 SKUs, with over 2 billion extended units sold in the US last year alone.
• In the pipeline are 30 approvals and launches (across oral solids, liquids, nasal sprays and ophthalmic formulations).

For more information visit www.rubicon.co.in

Incorporated in 2017 and operationalized in 2020, AdvaGen Pharma is an integrated specialty

pharmaceutical company, focused on providing innovative solutions for patients, customers, and partners

by developing, manufacturing, and marketing high quality prescription branded and generic

pharmaceutical products.

Job Description

Purpose This position will be responsible for regulatory communications for filings in US, managing meetings with USFDA, preparing regulatory strategies for global regulatory filings, regulatory assessments of MLR assets and filings, REMS activities and coordination, regulatory submissions for specialty / 505b2 projects and co-ordination with global regulatory teams.

Position / Job Title : Manager / Sr. Manager

Department : Regulatory Affairs

Reporting To : Director – Regulatory & IP

Location : New Jersey

Years of Experience : 10-15 years

• Manage regulatory communications for US filings.
• Manage meetings and discussions with USFDA.
• Prepare regulatory strategies for global regulatory filings.
• Responsible for regulatory assessments of MLR assets and filings.
• Coordinate with global regulatory teams.
• Manage regulatory submissions for specialty / 505b2 projects.
• Ensure business growth and operational excellence within regulatory set up.

Qualifications & Pre-Requisites

• Proficiency in Regulatory Affairs.
• Excellent communication, planning, analytical and interpersonal skills.
• Prior work experience with USFDA is preferred.
• Prior experience on specialty / 505b2 projects is preferred

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Other

Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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