Director Of Regulatory Affairs Jobs in Michigan

Job Title: Director of Regulatory Affairs Company: MRINetwork Location: Lansing, MI Description: Years of Experience:   10 years of industry experience in Regulatory Affairs for licensed biological products and biologics in advanced development.  Job Description:   Qualified candidate will oversee all regulatory activities for the  manufacturing facility for the licensed vaccine. • Oversee all regulatory activities required for routine lot release. • Plan and execute required regulatory filings to maintain product license and establishment registration • Plan and execute key regulatory filings in support of various manufacturing changes to enhance cGMP compliance, production capacity and product improvement • Support international licensing activities and oversees implementation of foreign registration requirements at the site• Provide regulatory guidance to site functional groups regarding all aspects of manufacturing and operational activities • Provide regulatory support to new product development activities at the site • Utilize technical knowledge and effectively apply regulations and guidelines to regulatory filings, and provide authoring, review, and coordination for quality submissions • Serve as regulatory liaison to the FDA and other regulatory authorities for assigned projects • Prepare and communicate regulatory risk assessment to the project teams and senior management • Manage the regulatory group and departmental budget and staffSpecial Skills Required:   Vaccine experience strongly preferred.  Bio-manufacturing and tech transfer experience will “seal the deal”.

Job Title: Regulatory Affairs Manager – Pharmaceutical Company: KSR Location: Troy, MI Description: This is a direct hire opportunity for an experienced Regulatory Affairs professional that has directly handled IND and NDA filings. The Regulatory Affairs Manager will be responsible regulatory project oversight, technical document writing and review, policy development, compliance monitoring, and creative regulatory strategy implementation. The RA Manager will also directly handle all regulatory submissions and communication with regulatory agencies and internal groups. The overall objective will be to provide strategic regulatory management/leadership throughout all levels of drug development.Requirements:

Job Title: Senior Manager of Regulatory Affairs Company: MRINetwork Location: Lansing, MI Description: Years of Experience:   4 + years of industry experience in Regulatory Affairs for products in advanced development (IND to BLA). Regulatory affairs experience in biologics.Job Description:   · Qualified candidate will serve as the senior regulatory member on Product Development Teams and provide regulatory oversight and guidance for the project teams. · Participate in developing regulatory strategy and oversees its integration to the overall product development plan and effective implementation.·  Provides guidance on FDA requirements regarding all aspects of product development and timing, logistics and operational recommendations. · Utilize technical knowledge and effectively apply regulations and guidelines to the product development process. · Develop regulatory submission strategies in agreement with product development objectives, and manages regulatory submission strategies. · Provide authoring, review, and coordination for quality submissions to regulatory agencies. · Serves as regulatory liaison to the FDA and other regulatory authorities for assigned projects. Will also prepare for Agency meetings, teleconferences, and other communications with regulatory agencies. · Prepare risk assessment for regulated aspects of product development, and communicates risks, impacts and mitigations to the project teams and senior management.Special Skills Required:   Vaccine, monoclonal antibody or polyclonal antibody experience preferred.  Bio-manufacturing and tech transfer experience helpful.

Job Title: Director Of Regulatory Affairs Quality Assurance Company: Stryker Medical Location: Kalamazoo, MI Description: GENERAL DESCRIPTION:Provides leadership and direction to the division’s regulatory affairs and quality assurance teams to ensure achievement of divisional business goals and objectives by ensuring distribution of quality products, as well as compliance with all applicable local, state and federal agencies and regulatory bodies.ESSENTIAL FUNCTIONS:1. Responsible for the selection, supervision, development and objective setting for teams consisting of managers and clerical/technical staff.2. Works with the executive, regulatory affairs and quality assurance teams to achieve Stryker Medical’s mission, vision and objectives.3. Responsible for setting and achieving regulatory and quality goals and objectives.4. Develops and maintains relationship with representatives of various regulatory agencies. Participates in audits and regulatory meetings as required.5. Ensures that Stryker Medical is aware of all changes in legislation and regulation as applied to our business.6. Regularly communicates department’s vision, quality goals and achievements to all employees as well as to senior staff on a regular basis. Communication may include, but is not limited to: business planning, business review, weekly meetings, etc.7. Participates in interviews, sales meetings and customer site visits as requested.8. Supports new business opportunities and acquisitions.9. Operates with honesty and integrity.10. Supports the growth and development of the team as a whole by investing in employee involvement and development by fostering personal growth, being responsible and accountable, being passionate towards the success of the business and treating all with dignity and respect. REQUIREMENTS - QUALIFICATIONS: Director Of Regulatory Affairs Quality Assurance • BA/BS degree in business or related discipline required. Master’s degree highly preferred.• Previous FDA experience highly preferred.• Must have six-eight years of proven leadership experience in a business environment (medical industry preferred)• Must possess excellent communication, strategic thinking, analytical and negotiation skills.• Basic skills - Time management, project management, inter-personal, reports and budget, stress management, people management, conflict management, customer service, Windows, advanced computer, statistics, financial systems, ISO13485, FDA regulation, organization structure, and office equipment.• Functional skills – personnel selection, financial systems, organization structure protocol, interdepartmental interface, interdivisional interface and P&L management.• Expected to handle complex or difficult situations as appropriate.• Must possess valid driver license in the state of residence.• Meets cognitive demands to include visual discrimination/memory, auditory discrimination/memory reading ability, independent decision making and retention of specific knowledge.Stryker Medical

Job Title: Regulatory Affairs Manager - Direct Hire Opportunity! Company: KSR Location: Troy, MI Description: Regulatory Affairs Manager – Direct Hire OpportunityKelly Clinical Research has a Direct Hire Regulatory Affairs Manager Opportunity available in Northern IN! Overall Responsibilities: Supports President, Company Sports Medicine and is responsible for managing regulatory affairs, regulatory compliance, and quality Assurance pursuant to federal, international and corporate regulatory requirements and standards.RESPONSIBILIITES:

Job Title: Director Of Regulatory Affairs & Quality Assurance Company: Stryker Location: Kalamazoo, MI Description: Provides leadership and direction to the division’s regulatory affairs and quality assurance teams to ensure achievement of divisional business goals and objectives by ensuring distribution of quality products, as well as compliance with all applicable local, state and federal agencies and regulatory bodies.ESSENTIAL FUNCTIONS:1. Responsible for the selection, supervision, development and objective setting for teams consisting of managers and clerical/technical staff.2. Works with the executive, regulatory affairs and quality assurance teams to achieve Stryker Medical’s mission, vision and objectives. 3. Responsible for setting and achieving regulatory and quality goals and objectives.4. Develops and maintains relationship with representatives of various regulatory agencies. Participates in audits and regulatory meetings as required.5. Ensures that Stryker Medical is aware of all changes in legislation and regulation as applied to our business. 6. Regularly communicates department’s vision, quality goals and achievements to all employees as well as to senior staff on a regular basis. Communication may include, but is not limited to: business planning, business review, weekly meetings, etc.7. Participates in interviews, sales meetings and customer site visits as requested.8. Supports new business opportunities and acquisitions. 9. Operates with honesty and integrity. 10. Supports the growth and development of the team as a whole by investing in employee involvement and development by fostering personal growth, being responsible and accountable, being passionate towards the success of the business and treating all with dignity and respect.