Our client, one of the largest Pharmaceutical companies in USA is looking for Regulatory Operations Specialist - II (Associate) at Millsboro, DE

Job Title: Regulatory Operations Specialist - II (Associate)

Location: Millsboro, DE

Pay Range: $35 - $39

Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day can be discussed when on assignment.

Note:

• NO PHD.

Must have:

• Regulatory labeling content review as per FDA guideline .

• Quality check of labeling content errors.

• Label artwork , label design review.

• Support the preparation of labeling documents , coordinating labeling document submissions to regulatory bodies.

• Looking for someone with labeling expertise in the pharmaceutical industry, vaccines manufacturing or GMP .

Qualifications:

Title: Regulatory Affairs US Biologicals labeling specialist

Minimum Education: Associate degree.

Preferred Education : Bachelor/Master's degree in Life Science.

Required Experience and Skills:

• With Associate , minimum 5-7 years of relevant experience within pharmaceutical labeling experience .

• With Bachelor's, minimum 4-6 years of relevant experience within pharmaceutical labeling experience .

• With Master's minimum 2-5 year of relevant experience within pharmaceutical labeling experience .

• Require someone with scientific background or familiarity with medical terminology .

• Require someone with excellent proofreading skills .

• Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, SharePoint, ADOBE.

Preferred/nice to have: Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology

Personality:

• Attention to details.

• Team Player.

• Able to follow directions.

• Can work independently once the trainings are complete.

• Able to make sure that regulations are met.

• Excellent communication and written skills.

• Open minded.

Typical day:

• Very intensive label-oriented job

• Need someone to hit the ground running.

• Label review and submission of labeling documents and artwork

• Label artwork, label design review.

• Quality check for label content and formatting as per FDA guidelines.

• Support the team with the review, revising labeling.

• Attention to details.

• Will prepare the label content following SOP’s and FDA regulations.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

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