Title:  Sr. Specialist, Regulatory Affairs (Onsite)

Job Title:      Sr. Specialist, Regulatory Affairs

Location:      Columbus, OH

Job Type:     Full time

Req ID:          5929

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 serving as a Subject Matter Expert (SME) for regulatory activities of R&D and/or lifecycle submissions to US FDA. This includes, but is not limited to, the compilation, review and submission of pre-approval (R&D) and/ or post-approval (lifecycle) submissions, such as original applications, amendments and deficiency responses, annual reports, supplements, supplement deficiency responses, and general correspondence for all regulatory submissions with a focus on Chemistry, Manufacturing and Controls (CMC) and Labeling. The candidate will be responsible for providing  expert support in applicable team meetings and when consulted, and operate as a SME regarding regulatory guidances/regulations and strategies to other members of the regulatory department, as well as to other departments. The candidate will be expected to mentor and provide regulatory support to other associates within the group, as well as within the organization. Requires minimal to no supervision.

Key Responsibilities:

• Compiles, reviews and submits applications, amendments and/or lifecycle changes (focus on CMC and Labeling) for the US market. Regulatory submissions such as annual reports, supplements, amendments for ANDAs and NDAs will be submitted to FDA as per the business needs and compliance with all FDA requirements.  Reviews change controls for regulatory impact and documentation to be included in regulatory submissions (i.e. batch records (manufacturing, packaging), specifications, analytical methods, etc.)
• Provides expert support as a regulatory subject matter expert and work closely with cross-functional departments (i.e. Quality Assurance, Quality Control, Technical Services, Product Development, Analytical Development, Project Management etc.) to provide the appropriate regulatory requirements/guidance, as applicable. Support will also be provided to cross functional teams for applicable submissions to US FDA.
• Performs thorough review of peer submissions to ensure submission quality and compliance with current guidances and regulations.  Serves as first line expert in fielding regulatory questions for the organization.
• Stays current with emerging regulatory guidance, and industry expectations and standards, and demonstrates the ability to translate these into process improvements or best practices.  Actively looks for ways to improve current processes within department and across the business to gain efficiency and quality submissions to US FDA.

Other duties as assigned

Skills:

Core Competencies:

• Excellent verbal and written communication skills with all levels of the organization
• Ability to multi-task
• Ability to manage timelines and priorities with minimal to no supervision.
• Ability to work independently without guidance.
• Attention to detail.
• Critical Thinking

Job-Specific Competencies:

• Thorough understanding and expert knowledge of regulatory requirements for pre-approval and/or post-approval submissions for the US Market.
• Thorough understanding of regulations and requirements for US market through expert  knowledge, FDA Guidance Documents and MAPPs, ICH Guidelines, Code of Federal Regulations as they pertain to generic drug products.
• Demonstrates the ability to ensure high quality submissions to US FDA are submitted as per the business.

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 Required:

Minimum of a Bachelor’s degree required in a science-related field

Experience Required:

Minimum of 6 years of regulatory submission experience in the pharmaceutical industry

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 regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Agency Notice:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.