Director, Regulatory Affairs - BioScience

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The Director Regulatory Affairs position is one of leading all RA operations and ensuring regulatory submissions maintains strict adherence to global requirements (FDA, TDP, TGA, EU, and PMDA). This position will monitor adherence to current Good Manufacturing Practices (cGMP) (e.g. 21 CFR Part 210/211 and ICH Q7), while ensuring the quality and integrity of the Company's products and quality standards. It will play a key role in communicating with customers regarding regulatory filings, and maintaining our registrations with global regulatory bodies.

• Enhances cGMP and FDA regulatory compliance and assists in preparation and maintenance of standard operating procedures.
• Develop and advance the knowledge base within the RA team
• Assist with internal, supplier, customer, and FDA audits.
• Lead the regulatory team to ensure Company's records pertaining to regulatory filings are maintained, including submitting annual reports and updates to DMFs
• Prepare master files for regulatory submission of new commercial products developed by the Company
• Stays current with regulations pertaining to the Company's products
• Informs site leadership of changes or validations necessary to maintain compliance with cGMP
• Lead customer interactions to ensure successful regulatory submissions and continued approvals
• Works closely with QA, QC, and production to ensure the Company complies with all regulatory requirements with the appropriate local, state, federal, and global regulations.
• Direct cross-functional groups at the establishment to update procedures based on current regulatory best practices.
• Ensure permit applications and renewals to local, state, and federal governing bodies are submitted within required timeframes
• Point of contact for regulatory correspondence to facilitate approval of finished drug products and medical devices utilizing our products.
• Ability to manage priorities to complete important tasks in a timely manner, while maintaining focus on long-term strategies and goals
• Participate and/or lead meetings with existing and new customers or partners

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions.

• Bachelor's degree from a regionally accredited four-year college or university in science or related field and 10+ years of experience in the pharmaceutical or related industry; or equivalent combination of education and experience, required
• Master's degree preferred
• 7+ years experience in team development or management, required
• Knowledge and understanding of eCTD format
• Experience dealing with global regulatory bodies (e.g. FDA, USDA, TGA, TPD, and EU competent authorities)
• Ability to manage priorities to achieve company goals
• Excellent planning and organizational skills with demonstrated multi-tasking and project management experience.
• Strong knowledge of compendial requirements for drug substances and products (e.g. USP, EP, and JP).
• Detailed understanding of cGMP (ICH Q7, CFR Parts 210/211, CFR Part 11)
• Excellent written and verbal communication skills.
• Strong attention to detail.
• Travel up to 20% for conferences, customer meetings, and / or audits.

• Provides leadership and guidance within the Regulatory Affairs team
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems

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EEO/AA Information

Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law.

If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.