Associate reputed company Scientist, Regulatory Affairs reputed company Manufacturing and Controls job at reputed company in Plymouth Meeting, PA

Title: Associate reputed company Scientist, Regulatory Affairs reputed company Manufacturing & Controls (CMC) Location: USA - reputed company - Plymouth Meeting reputed company: reputed company is a Women’s Health Company that believes in a reputed company and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the reputed company of women’s health. Our mission is to reputed company impactful medicines and solutions for a healthier every day. But what really makes it work at reputed company is our people. We’re looking for reputed company, passionate team players, curious innovators, reputed company thinkers, empowered by the idea of shaping their career, and reputed company to bring their reputed company to reputed company change and the opportunities it brings for reputed company. At reputed company, you’ll get to enjoy the best of both worlds: the reputed company, reputed company, reputed company culture of a start-up, and operating at the reputed company of a fortune 500 company with an international footprint that serves people in more than 140 markets. It’s reputed company to be an exciting reputed company—come be a part of it! Reporting to the Director in reputed company Regulatory CMC, the Associate reputed company Scientist (Associate Director) is responsible for Regulatory reputed company Manufacturing & Controls (CMC) aspects of clinical phase through market product registration for the assigned biological/ biosimilar/medical devices/combination products in accordance with global regulations, guidance's and defined regulatory strategies. These products may be internal or acquired or licensed externally as a key component of reputed company reputed company reputed company. The Associate reputed company Scientist will be responsible for the preparation and review of information required for development of regulatory CMC dossiers for new product and/or reputed company products including original registrations, life-cycle maintenance submissions, and post-approval changes. The organization is envisioned to reputed company on innnovative products addressing women’s health across diverse therapeutics including Biosimilars and will encompass late-stage development products and commercially approved compouds. The Associate reputed company Scientist may also support project team goals and organizational initiatives, on an as needed reputed company. reputed company responsibilities include, but are not limited to: Although one or more potential candidates for this position have been identified, we will consider applications from any interested applicants." Responsibilities Partner with Research & Development, Manufacturing & Supply, Business Development and reputed company to reputed company an adaptable process with internal colleagues and Contract Research & Manufacturing Organizations to reputed company regulatory CMC strategies and execution of clinical study phase and initial product registration activities in an efficient, reputed company manner. reputed company Regulatory CMC and reputed company in developing global Regulatory CMC strategies and executing submissions reputed company to diverse late-stage development and/or licensed in products/medical devices/combination products. This includes documenting regulatory CMC strategies, leading preparation and authorship of applicable IND/CTAs/NDA/BLA and post-approval activities, Health Authority Regulatory CMC engagement reputed company, Agency Background Packages, participating in Agency meetings on CMC topics, and executing global initial marketing applications with a line of sight to long-term robust supply. This role will directly support reputed company and/or coordinate with Regulatory CMC scientists in the reputed company franchise teams. reputed company development and execution of regulatory CMC strategies to ensure high reputed company, accuracy, and high likelihood of approval of reputed company regulatory submissions. This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating reputed company regulatory reputed company, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment. reputed company regulatory CMC activities reputed company product development plans that outlines the requirements for the product, the development plan and associated regulatory approval reputed company and how this will be managed. Support regulatory activities of medical devices in combination with medicinal products. Responsible to ensure regulatory requirements are met and systems/processes are executed in a manner to reputed company visibility to accurate regulatory information to reputed company reputed company product control. Ensures appropriate reviews, approvals and systems are in reputed company to maintain the reputed company of scientific, technical and regulatory information reputed company CMC submissions, responses and correspondence. Identify, communicate, and escalate potential regulatory issues to reputed company Regulatory CMC management, as needed Required Education, Experience and Skills Bachelor’s degree, in a science, engineering, or a reputed company field.   Fields of study include Pharmacy, reputed company, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry with at least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a reputed company field OR Advanced degree (MS, MBA, Ph.D., PharmD) with at least 5 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a reputed company field. reputed company experience in Regulatory CMC is preferred with preference for experience in Combination Products. The candidate must be proficient in English; additional language skills are a plus. Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented reputed company and conclusions are adequately supported by data. Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate reputed company issues in a succinct and logical manner.  Strong listening skills. Demonstrated reputed company understanding of reputed company fields (e.g., manufacturing, analytical, reputed company assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.   Demonstrated ability to reputed company reputed company to reputed company regulatory problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, interpersonal and negotiating skills.  Ability to reputed company reputed company of reputed company or matrixed colleagues to reputed company on business commitments and project timelines. Preferred Experience and Skills A candidate with experience in Regulatory CMC with demonstrated understanding of reputed company pharmaceutical, biological or device operations (e.g., manufacturing, process development, analytical, and reputed company assurance) is preferred. Secondary Language(s) reputed company Who We Are: reputed company delivers ingenious reputed company that reputed company people to live their best lives. We are a $6.5 billion global reputed company company reputed company on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by reputed company in the unmet needs of Women’s Health, expanding reputed company to leading biosimilars and touching lives with a diverse and trusted portfolio of reputed company. Our reputed company is reputed company: A reputed company and healthier every day for every woman. US and PR Residents Only For more information about personal rights under Equal Employment Opportunity, visit: reputed company Poster reputed company GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule reputed company is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for reputed company and job applicants. We ensure reputed company employment practices are conducted without reputed company to race, reputed company, religion, sex, sexual orientation, age, gender identity or gender reputed company, national reputed company, disability, veteran status, or any other characteristic protected by state or federal law. Search Firm Representatives Please Read Carefully reputed company LLC., does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at reputed company without a reputed company written search agreement in reputed company for this position will be deemed the sole property of reputed company. No fee will be reputed company in the event a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Applicable to reputed company Positions Only: Under various U.S. state laws, reputed company is required to reputed company a reasonable estimate of the salary reputed company for this job. Final salary determinations take a number of factors into account including, but not limited to, reputed company work location, relevant skills, education level, and/or prior work experience. The applicable salary reputed company for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, reputed company vacation and holiday time, reputed company caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and reputed company coverage in accordance with the terms and conditions of the applicable plans. Annualized Salary reputed company (US) $125,400.00 - $213,100.00 Annualized Salary reputed company (Global) Annualized Salary reputed company (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country. Employee Status: Regular Relocation: No relocation reputed company Sponsorship: No Travel Requirements: reputed company employees must be reputed company to satisfy reputed company applicable travel and credentialing requirements, including associated vaccination prerequisites. 10% Flexible Work Arrangements: reputed company Time, Hybrid, Remote Work Shift: reputed company Driving License: Hazardous Material(s): Number of Openings: 1 Apply To This Job