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Senior Associate, Regulatory Affairs

2 months ago

Bristol, United States USAntibiotics, LLC Full time

Overview USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We're always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence. Responsible for support of regulatory affairs activities under direction of department management. Activities may include but are not limited to: *Compilation/review of Annual Reports, Advertising/Promotional material, and product labeling. *Electronic assembly and publication of original applications, amendments, and supplements. *Assessment of proposed changes to manufacturing facilities, processes, and/or controlled documents.

ROLES &

RESPONSIBILITIES: Product support activities: Compilation and review of FDA Submissions (e.g., NDA Filings, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with change control review/approval and management. Coordinate

compilation/review

of Advertising/Promotional

material

with marketing

for

management's review

and approval. Submit

Advertising/Promotional

materials

to

FDA's

OPDP

via

electronic

methods. QUALIFICATIONS: Additional

responsibilities

as

assigned

by

management.

Bachelor's degree in a scientific area of interest required (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing). Minimum of four years of direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated

environment . KNOWLEDGE, SKILLS AND

ABILITIES:

Competency

with

regulations,

policies,

and

procedures

relating

to

company

and

regulatory

guidelines Ability

to

multitask

and

manage

multiple

projects

with

interdisciplinary

teams Effective

communication

(verbal

and

written)

with

external

and

internal

customers,

vendors,

and

regulators. Participation

and

familiarity

with

post-approval

submissions

to

FDA,

and

with

ad/promo

materials

to

FDA

as

well as hands-on

experience reviewing

and approving labeling and marketing regulatory

materials. Strong

planning

and

organizational

/

project

/

workload

management

skills. Ability

to

work

under

deadline

pressure

/

rapidly

shifting

priorities

and

manage

multiple

projects. Strong

ability

to

work

independently

as

well as

in

a

team

environment. Ability

to

drive

projects

to

completion

with

minimal

guidance. Solid

interpersonal

(verbal

and

written)

communication

skills

at

all

levels. Formal

project

management

skills

are

a

plus. Broad career

progression including experience

in

multiple departments

in pharmaceutical,

drug

development

and/or

manufacturing industry

is

a plus.

Regulatory

publication

experience using eCTD software is

a plus. Experience

in

the

use

of

PC-based

word

processing

software,

databases,

spreadsheets,

and

Adobe

Acrobat,

including

database

management

and

support.

SAP

experience

a

plus. Proficient in the use

and preparation of electronic regulatory submissions under

FDA and

ICH

Common Technical

Document (CTD) XML-compliant

schema

is

preferred. Experience

with

metrics

management

and

reporting. Proven

negotiation

skills

with

internal

and

external

stakeholders. EEO Statement USAntibiotics is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender, gender identity and expression, national origin, age, disability or protected veteran status. We celebrate diversity and are committed to creating an inclusive environment for all of our associates.

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