Director Of Regulatory Affairs Jobs in Missouri

Job Title: Regulatory Affairs Manager Company: Monsanto Location: Saint Louis, MO Description: The U.S. Biotechnology Regulatory Affairs Team is seeking a Regulatory Affairs Manager who will support the development and implementation of regulatory strategies, product dossiers, agency submissions, and will lead efforts to obtain and maintain U.S. and global regulatory approvals for Monsantos agricultural biotechnology-derived products, such as corn, cotton, soybean, and specialty crops. The successful candidate will work closely with colleagues as new products are handed-off to regulatory, fully-characterized to ensure product safety, and ultimately commercialized for sale and distribution. This role works in close coordination with many functional areas within a matrix organization including Discovery, Global Regulatory Affairs, Pipeline Regulatory, Regulatory Technology Centers, Project Management, Crop Teams, Breeding, Industry Affairs, Public Affairs, U.S. Markets, Legal, and Trait Stewardship. This individual will work in a cross-functional capacity to build and implement approval strategies to obtain both U.S. and international regulatory approvals, use their scientific/technical background to provide input on regulatory reports, and prepare documents to support product registrations in the U.S. and other production and key export countries.· Key Deliverables:o Provide the leadership and delivery of global regulatory strategies for Monsantos products in collaboration with colleagues in the global Regulatory organization;o Provide input and guidance in regulatory study reports to ensure that appropriate national (e.g., USDA, EPA, FDA) and international data (e.g., CODEX, OECD) requirements are met;o Prepare regulatory submissions, coordinate responses to questions from regulatory authorities, and develop other related documents (e.g., white papers, position statements, etc.) to obtain regulatory approvals in key export and production countries; ando Collaborate with the business teams on the identification, implementation, and management of regulatory acceptance and stewardship issues.

Job Title: Chemistry Regulatory Affairs Manager (001D4) Company: Monsanto Location: Saint Louis, MO Description: The Chemistry Regulatory Affairs Team is seeking a Regulatory Affairs Manager who will work with a cross-functional team to build regulatory approval strategies, data and submission packages to obtain and maintain global approvals for Monsanto's chemical pesticide products.  The successful candidate will work closely with colleagues in Chemistry and Biotech Regulatory Affairs, the Regulatory Science Technology Centers, Legal and in critical functions in Chemistry Technology and the Crop Protection Division, and Seeds and Traits organizations.Areas of focus may include developing and implement strategies to gain regulatory approval of seed treatment products for core row crops and vegetables and herbicide products for general weed control as well as uses in Monsanto's herbicide-tolerant crops. This position will collaborate on the design and conduct of required regulatory studies and will prepare necessary documents to obtain and support product registrations in the US and internationally and, as needed, the establishment of maximum residue limits in the US and in key importing countries and CODEX.Major Responsibilities: Collaborate with colleagues in the Regulatory organization to develop global regulatory strategies; develop and manage project plans and coordinate regulatory studies needed to obtain approvals; participate in defining and developing new product concepts; setting criteria for acceptable ingredients for new end-use formulations; manage product labeling; prepare submission packages that may include study reports, data summaries, proposed product labeling, confidential statements of formula, and rationales for approval; respond to questions from customers; interact directly with regulators; and collaborate with the business teams on the identification and management of regulatory and stewardship issues.An advanced degree (MS/PhD) is preferred or BA/BS in one of the chemical or biological sciences with relevant experience.Background in agriculture, chemistry, biochemistry, toxicology, weed science, agronomy, plant pathology, pesticide environmental chemistry, plant biochemistry or other relevant scientific discipline is preferred.Knowledge of pesticide regulations and the processes for registration of pesticide products under FIFRA or experience in working with the US EPA and/or international pesticide regulatory agencies would be considered a strong plus.

Job Title: Director of Regulatory Affairs - NDA Company: Covidien Location: Saint Louis, MO Description: Employer Information About Covidien At Covidien, we're passionate about making doctors, nurses, pharmacists and other medical professionals as effective as they can be. Through ongoing collaboration with medical professionals and organizations, we identify clinical needs and translate them into proven products and procedures. Over the years, we've pioneered a number of medical advances that spans medical devices, imaging solutions, pharmaceuticals and medical supplies, we serve healthcare needs in hospitals, long-term care and a....more info View all our jobs Job The position of Director of Regulatory Affairs, in the Regulatory Affairs Department, requires an individual with direct regulatory affairs experience and experience managing a group of regulatory professionals in the development of new drug development programs. This person will be responsible for the formation of the global regulatory strategy involving the direction and management of resources and activities in the development and implementation of regulatory strategies leading to the rapid submission and approval of high quality dossiers meeting the requirements of Health Authorities and the needs of the company; ESSENTIAL FUNCTIONS: 1. Maintains current high level knowledge of regulations, the regulatory process, and the application of regulations to assigned products - expands regulatory background through work on projects, researching available documents and attending relevant training. Anticipates how future developments in the regulations for relevant therapeutic areas may effect drug development process. 2. Liaison with regulatory agencies during the development process and for assertively and successfully prosecuting marketing applications to ensure their timely approval. 3. Oversees those activities that lead towards the submission of high quality clinical trial applications, which meet clinical development timelines. 4. Directs resources and assures that activities will lead to the provision of adequate and proactive regulatory guidance into the Core Development Teams for new product development to ensure that the resultant development package is consistent with ICH guidelines and global regulatory agency expectations for new products. 5. Interacts with key functions of the company including R&D, Clinical Development, Manufacturing, Quality Assurance and Marketing. 6. Responds to inquiries from various departments regarding regulatory strategy, post-approval changes, etc. in a timely manner. Insures proper research was conducted prior to communicating regulatory strategy. 7. Drafts, circulates, and maintains department work instructions of essential job functions. Insure compliance with procedures among staff. 8. Develops coaching partnerships with direct reports. Provides training and development plans. Generates team goals and manages yearly progress of goal completion. Provides reports with challenging assignments and opportunities to address their development needs. Provides continuous feedback and end-of-year performance review. 9. Provides training in various RA areas, including but not limited to: documentation review, EZSubs utilization, SOPs, work instructions, submission procedures, timeline management, regulatory procedures, FDA application types, review process, etc. Develops training programs for new department members. 10. Performs due diligence on Regulatory information for external collaboration projects. Provides regulatory strategy and support to contact manufacturers and partner companies, as necessary. Provides templates for document authoring and directs timeline, as appropriate. 11. Assists plant site RA with regulatory issues. Serves as liaison to site RA and QA personnel for product life cycle management. Provides regulatory requirement support and direction as necessary. Provide assistance during FDA audits as necessary. 12. Manages those activities that lead towards the submission of high quality CMC applications, facilitating pharmaceutical and clinical development timelines. NOTES: Local Country Candidates Only. Additional Salary Information: Relocation, Health, 401k, Vacation and Holiday Pay

Job Title: Chemistry Regulatory Affairs Manager Company: Monsanto Location: Saint Louis, MO Description: The Chemistry Regulatory Affairs Team is seeking a Regulatory Affairs Manager who will work with a cross-functional team to build regulatory approval strategies, data and submission packages to obtain and maintain global approvals for Monsantos chemical pesticide products. The successful candidate will work closely with colleagues in Chemistry and Biotech Regulatory Affairs, the Regulatory Science Technology Centers, Legal and in critical functions in Chemistry Technology and the Crop Protection Division, and Seeds and Traits organizations.Areas of focus may include developing and implement strategies to gain regulatory approval of seed treatment products for core row crops and vegetables and herbicide products for general weed control as well as uses in Monsantos herbicide-tolerant crops. This position will collaborate on the design and conduct of required regulatory studies and will prepare necessary documents to obtain and support product registrations in the US and internationally and, as needed, the establishment of maximum residue limits in the US and in key importing countries and CODEX.Major Responsibilities: Collaborate with colleagues in the Regulatory organization to develop global regulatory strategies; develop and manage project plans and coordinate regulatory studies needed to obtain approvals; participate in defining and developing new product concepts; setting criteria for acceptable ingredients for new end-use formulations; manage product labeling; prepare submission packages that may include study reports, data summaries, proposed product labeling, confidential statements of formula, and rationales for approval; respond to questions from customers; interact directly with regulators; and collaborate with the business teams on the identification and management of regulatory and stewardship issues.

Job Title: MANAGER - REGULATORY AFFAIRS (7322) Company: MRINetwork Location: Springfield, MO Description: Manager - Regulatory Affairs (7322) Responsibilities:Advocate positions with local, state, and federal officials and staff.         Monitor and analyze regulatory filings at the state and federal levels. Develop and maintain working knowledge of electric power industry restructuring and competitive market design. Review, analyze, and communicate company positions in legislation development and implementation. Develop, coordinate, and implement regulatory strategy. Coordinate company participation in trade associations, Manage participation in regulatory proceedings including outside counsel and consultants in regulatory proceedings. Assist in regulatory compliance  QualificationsBachelors degree, advanced degree such as JD or MBA a plus. Two or more years of government affairs or regulatory work experience. Strong communication and negotiation skills. Self-motivated with the capability to manage and prioritize multiple projects. Ideally have previous experience in the utility or other regulated industry. Frequent travel is required Compensation:  $100,000 - $130,000  (plus bonus)