Regulatory Affairs Director jobs in Cary, NC

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Associate Director, Regulatory Affairs
  • Mayne Pharma
  • Raleigh, NC FULL_TIME
  • Position Overview:

    This position reports to the Vice President, Regulatory Affairs and Quality and has the overall responsibility for managing pre and post marketing regulatory activities for all company products.

    ·         Prepare and submit regulatory submissions to the FDA.  These submissions include original new drug applications (NDAs and INDs), amendments, supplements, FDA meeting requests and briefing packages.

    ·         Lead the electronic submission process.

    ·         Ensure that all submission and other RA software licenses are current.

    ·         Review and approve required CMC, Clinical, and Nonclinical reports, supplemental submissions and other postmarketing commitments to update and maintain product approvals and registrations.

    ·         Provide training on current and new regulatory requirements to ensure company-wide compliance.

    ·         Communicate the impact of new, existing and pending regulations, guidelines and standards to internal stakeholders.

    ·         Review and approve labeling updates.

    ·         Review and approve promotional materials for submission to OPDP.

    ·         Submit/review change controls to determine the level of change and consequent submission requirements.

    ·         Provide regulatory input for product recalls and recall communications.

    ·         Manage systems to ensure that adverse events and product safety issues are reported to regulatory agencies.

    ·         If required, negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

    ·         Assess the acceptability of quality, CMC and clinical documentation for inclusion in regulatory submissions.

    ·         Keep an accurate and up-to-date record of all submissions, CRL, PAS and all other regulatory communications with FDA.

    ·         Formalize and establish Regulatory Standard Operating Procedures, as required, and maintain current records.

    ·         Consult with internal stakeholders and external partners to identify and review documentation required to address regulatory issues.

    ·         Interact with outside organizations that might assist with regulatory needs such as those that assist in preparing SPL, external auditors, and consultants.

    ·         Assist during FDA inspections and audits, as required.

    Minimum Requirements:

    ·         Bachelor’s degree or higher in Pharmacy, Chemistry, Biology or related field with 6 to 10 years of pharmaceutical regulatory affairs experience

    Preferred Requirements:

    ·         Knowledge of ICH guidelines and FDA guidance documents relating to  work description

    ·         Proven ability of attention to details

    ·         Strong oral and written communication skills

    ·         Knowledge of GMP regulations

    ·         Knowledge of CFR regulations pertaining to NDAs and ANDAs

    ·         Knowledge and skilled at using e-CTD submission software. 

    Other Skills/Abilities:

    ·         Ability to maintain high degree of confidentiality

    ·         Excellent interpersonal and written communication skills

    ·         Ability to work independently

    ·         High proficiency in database/spreadsheet programs: Excel, Word, PowerPoint, and ability to learn new programs as needed

    ·         Exhibit positive, constructive, decisive demeanor

    ·         Excellent follow-up skills; demonstrated ownership to provide real resolutions

    ·         Ability to be flexible in workload supporting department

    ·         Excellent organizational skills and detail oriented

    ·         Maintain accurate documentation

    ·         Ability to multi-task

    Physical Requirements:

    ·         Position may require some travel

    ·         Position includes working in a fast-paced team-based environment.

     

    Equal Opportunity Employer Women/Minorities/Disabilities/Veterans

     

    Any communication you receive from Mayne Pharma will never come from a personal email domain or chat service such as "gmail" or "Google Chat".  All official communication from Mayne Pharma will be received from our company email domain - @maynepharma.com.

  • 10 Days Ago

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Director, Regulatory Affairs
  • Merz Therapeutics
  • Raleigh, NC FULL_TIME
  • Who We Are: Harvesting Hope with a Growing Family At Merz Therapeutics, we take a nurturing approach to our organization – treating colleagues like family, embracing our whole selves and creating a co...
  • 1 Month Ago

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Associate Director / Director, Regulatory Affairs
  • Merz Therapeutics
  • Raleigh, NC FULL_TIME
  • Who We Are: Harvesting Hope with a Growing Family At Merz Therapeutics, we take a nurturing approach to our organization – treating colleagues like family, embracing our whole selves and creating a co...
  • 21 Days Ago

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Associate Director / Director, Regulatory Affairs
  • Merz Pharmaceuticals, LLC
  • Raleigh, NC FULL_TIME
  • Who We Are: Harvesting Hope with a Growing Family At Merz Therapeutics, we take a nurturing approach to our organization – treating colleagues like family, embracing our whole selves and creating a co...
  • 8 Days Ago

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Associate Director, Regulatory Affairs (CMC)
  • Kriya Therapeutics Inc
  • Morrisville, NC FULL_TIME
  • Who You Are The Associate Director, Regulatory Affairs (CMC) works closely with the manufacturing department and individual program teams to ensure CMC compliance and promote overall regulatory succes...
  • 19 Days Ago

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Director, Regulatory Affairs Advertising & Promotion
  • Sobi
  • Raleigh, NC FULL_TIME
  • Company DescriptionSobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and provi...
  • 12 Days Ago

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0 Regulatory Affairs Director jobs found in Cary, NC area

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Director, State Affairs
  • Alzheimer's Association
  • Raleigh, NC
  • Position Summary: The North Carolina Director of State Affairs serves as the principal staff for state government affair...
  • 3/28/2024 12:00:00 AM

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Cardiovascular Program Manager RN
  • Clinical Management Consultants
  • Raleigh, NC
  • An exciting opportunity to work for a top-ranked health system as their Cardiovascular Program Manager RN in North Carol...
  • 3/27/2024 12:00:00 AM

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Bank Chief Financial Officer
  • Continental perspective group NC. inc.
  • Raleigh, NC
  • Job Description Job Description JOB TITLE: Chief Financial Officer REPORTS TO: Chief Executive Officer CLASSIFICATION: F...
  • 3/26/2024 12:00:00 AM

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Director, Regulatory Affairs
  • The Judge Group
  • Raleigh, NC
  • Who We Are: Harvesting Hope with a Growing Family At Merz Therapeutics, we take a nurturing approach to our organization...
  • 3/26/2024 12:00:00 AM

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Executive Director, Global Asset Lead - Migraine
  • The Judge Group
  • Raleigh, NC
  • **This role can be based anywhere in the US but requires regular travel to Merz Therapeutics North America office in Ral...
  • 3/26/2024 12:00:00 AM

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Executive Director Specialist RN
  • Careerbuilder
  • Cary, NC
  • Gentiva Executive Director Specialist RN Cary , North Carolina Apply Now Gentiva Hospice is a member of the Gentiva fami...
  • 3/25/2024 12:00:00 AM

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Deputy Executive Director of Programs Operations
  • Raleigh Housing Authority
  • Raleigh, NC
  • Job Description Job Description Deputy Executive Director of Programs Operations Salary Range: $117,989 to $147,949 per ...
  • 3/24/2024 12:00:00 AM

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Global Program Director
  • HCLTech
  • Cary, NC
  • HCLTech is looking for a highly talented and self- motivated Veeva COE Head to join it in advancing the technological wo...
  • 3/24/2024 12:00:00 AM

Cary /ˈkæri/ is the seventh-largest municipality in North Carolina. Cary is predominantly in Wake County, with a small area in Chatham County in the U.S. state of North Carolina and is the county's second-largest municipality, as well as the third-largest municipality in The Triangle of North Carolina after Raleigh and Durham. The town's population was 135,234 as of the 2010 census (an increase of 43.1% since 2000), making it the largest town and seventh-largest municipality statewide. As of April 2018[update], the town's estimated population was 162,025, though Cary was still considered a tow...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$164,275 to $233,963
Cary, North Carolina area prices
were up 1.5% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020