Regulatory Affairs Manager jobs in Columbia, SC

Description

Position Summary:

• Prepare and submit regulatory filings to health authorities, ensuring accuracy, completeness, and compliance with applicable regulations.
• Coordinate with internal teams (e.g., Clinical, Quality, Manufacturing) and external partners (e.g., contract research organizations) to collect necessary data and documents for submissions.
• Assess regulatory requirements for product registration and approval in various markets worldwide.
• Lead cross-functional project teams to ensure alignment and progress toward regulatory and business objectives.
• Assist with duties associated with Nephron’s scientific development teams: Business Development, Quality Assurance,      Production, Compliance, and Research & Development.
• Assist in collection of data facilitating development strategies to support needs of the company for new products and interaction with senior management regarding changes in direction. 
• Assist with additional work duties or responsibilities as evident or required.
• Perform other duties as assigned or apparent.

Primary Accountabilities:

NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

· Lead cross-functional project teams to ensure alignment and progress toward regulatory objectives.

· Develop project plans, timelines, and budgets for regulatory activities, and monitor progress to ensure timely completion

· Ability and willingness to change direction and focus to meet shifting organizational and business demands which includes the ability to multi-task and meet strict deadlines.

· Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and regulatory agencies.

· Proven ability to manage multiple projects simultaneously and drive them to successful completion.

· Knowledge of FDA and Business regulations. 

· Excellent organizational skills and attention to detail.

· Intermediate to advanced computer skills. Experience with Adobe Acrobat, Excel, Power Point and Word, and ability to learn new computer programs. Microsoft Project Manager a plus.

· Excellent interpersonal, communication, public speaking, and presentation skills 

· The ability to manage a multitude of cross-departmental relationships and to be accurate and current with data and information.

· The ability to take strategic objectives and assist the Regulatory Affairs management in taking responsibility and accountability, motivate and influence others, think globally and leverage diversity.

· Assist in the collection of performance measures and metrics to assess risk and opportunities for the company and present those findings. 

· The ability to effectively manage one’s self, demonstrates integrity, be productive under pressure, and achieve developmental goals.

· The ability to utilize knowledge to obtain information regarding the competition to determine business strategies and decisions.

· Travel Required

· Salary range: Based on experience

· Hours of work: Based on business needed

Knowledge, Skills & Abilities:

· Bachelor's degree in a scientific or related field; advanced degree (e.g., PharmD, PhD) preferred.

· Relevant scientific degree, Bachelor of Science or Business degree preferred, with at least 2 years additional clinical or pharmaceutical experience. 

· Relevant scientific degree with at least 1 year additional experience in Regulatory Affairs strongly preferred.

· Strong understanding of drug development processes and regulatory requirements for drug approval.

· The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.

· Additional Requirements:

· Ability to read, analyzes, and interprets complex scientific and medical reports and journals, as well as government regulations and guidance documents.

· Excellent written and verbal communication skills, along with the ability to effectively present information to regulatory authorities.

· Ability to write submissions and regulatory correspondence that conforms to a prescribed style and format.

· Critical thinking skills and ability to follow-through. 

EEO Statement: 

Nephron is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.