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Senior Regulatory Affairs Associate (Labelling)

EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE - FULLY FLEXIBLE

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

India

Offer summary

Qualifications:

4+ years of experience in drug development, Knowledge of key labeling regulations/guidance, Proficiency in SPL and electronic submission.

Key responsabilities:

Manage regulatory affairs labeling projects
Collaborate with cross-functional teams
Complete job-related responsibilities and self-development activities

Parexel Pharmaceuticals XLarge https://www.parexel.com/

10001 Employees

See more Parexel offers

Job description

Your missions

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

Project Execution:

Regulatory Affairs Labeling

Must have 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)
The ability to research and create comparator labeling documents.
Strong understanding and experience creating annual reports.
The ability to collaborate with Tech Ops for artwork implementation.
Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
Electronic document management systems use and / or electronic submission experience.
Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.

PAREXEL-related Activities:

Meets established metrics as specified in scorecard on an annual basis
Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects as requested by management
Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)

Skills:

Project management knowledge
Client-focused approach to work
Results orientation
Teamwork and collaboration skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving skills
Proficiency in local language and extensive working knowledge of the English language

Business Development:

Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience
Communicates potential new business leads to PC management and account managers
May participate in project scoping calls and/or proposal preparation with the support of senior colleagues

Knowledge and Experience: