Sr. Specialist, Regulatory Affairs (Onsite)-5678

Job Title:      Sr. Specialist, Regulatory Affairs – Injectables

Location:      Bedford, OH (Onsite)

Job Type:     Full time

Req ID:         5678

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Sr. Specialist, Regulatory Affairs to join our team.  In this role, you will be responsible for supporting Hikma’s pre-approval submission business needs (ANDAs, NDAs, amendments, etc.) by planning, compiling, publishing and ensuring high-quality submissions are filed on time and responses to any subsequent health authority comments are complete and timely. You will work closely with Formulation, Analytical Labs, and R&D Project Management.

 

Key Responsibilities:

• Compiles and submits original Abbreviated  New Drug Applications (ANDAs) and New Drug Applications (NDAs), post-approval supplements (prior approval supplements, CBE-30 and CBE-0) to support new product development to the FDA.
• Reviews and researches FDA regulation guidance, and precedents in order to ensure new FDA requirements are met, reducing review cycles and facilitating the earliest approval date.
• Manages multiple projects with supervisor in order to gain experience and knowledge regarding regulatory requirements. 
• Attends educations courses and seminars and present summary of information to the department concisely.
• Electronic processing and publishing of submissions to support business filing needs by utilizing in-house electronic software and checklists.

 

 

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Education:  Bachelor’s degree in a scientific-related discipline
• Experience:   Two – five years of experience in laboratory environment in a highly-regulated industry (food, nutrition)

 

Preferred Qualifications:

• Experience:  Prefer two – five years of experience in laboratory or regulatory affairs in the pharmaceutical industry

Skills:

• Demonstrated excellent written and verbal communication skills
• Ability to multi-task
• Ability to effectively contribute in a team environment
• Demonstrated attention to detail is critical and essential
• Possess professional experience in scientific document preparation, utilizing strengths in writing, organizational skills, and attention to detail.
• Creativity and innovative thinking
• Collaboration with internal customers to assess completeness of documentation and information for submissions to FDA.

 

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.  Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).  Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

 

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

 

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without rega