RegOps Dossier Manager
2 weeks ago
U.S. RegOps Dossier Manager
Use Your Power for Purpose
We're committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our regulatory submissions are prepared, published, tracked, and quality-controlled to meet the highest standards. Your contributions will help us bring life-saving medicines and vaccines to patients around the world more efficiently and effectively.
What You Will Achieve
In this role, you will:
- Assist in the preparation, publication, tracking, and quality control of regulatory submissions, ensuring compliance with document management standards.
- Coordinate enterprise-wide regulatory management systems, train team members, and develop and implement strategic plans.
- Contribute to moderately complex projects, manage your own time to meet targets, and develop plans for short-term work activities.
- Execute designated operational tasks through the use of standards and tools, conforming to regulatory submission milestones and obligations.
- Support the interpretation of regulatory guidelines to produce business requirements and ensure their implementation at local and regional levels.
- Collaborate with team managers to forecast and manage project-specific resources, utilizing flexible resourcing and global load sharing as standard practice.
- Act as a Subject Matter Expert in dossier types and processes and handle curriculum and training assignments.
Here Is What You Need (Minimum Requirements)
- BA/BS with 2+ years of experience or MBA/MS with any years of experience
- Deep understanding of the drug development process, regulatory affairs, and submission management
- Familiarity with systems and electronic technologies that support submission and planning activities
- Exceptional organizational skills and a keen attention to detail
- Ability to present scientific data effectively, both verbally and in writing
- Proficiency in English
Bonus Points If You Have (Preferred Requirements)
- Master's degree
- Familiarity with pharmaceutical organizational structures, systems, and culture
- Experience in project management
- Strong analytical and problem-solving skills
- Ability to work independently and as part of a team
- Ability to manage multiple projects and priorities simultaneously
- Experience with global regulatory submissions and requirements
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs Experience LevelMid Level-
Regulatory Affairs Manager
4 weeks ago
Delhi, India Personnel Search Services Group Full timeJob Description About the client: PSS has been mandated to hire a Regulatory Affairs Manager for one of the leading pharmaceutical companies in India. Job Purpose To register Formulation products in the European markets, handling all submissions and taking care of all queries. Key Responsibilities - The candidate should have sound knowledge of all Regulatory...
-
Market Access Manager
2 weeks ago
India vueverse. Full timeJob Summary:We are seeking an experienced and strategic Manager – Market Access to lead market access activities, ensuring optimal pricing, reimbursement, and patient access for pharmaceutical products. The role requires strong cross-functional collaboration with Commercial, Medical Affairs, Regulatory, and Health Economics teams to develop and execute...
-
Market Access Manager
2 weeks ago
India vueverse. Full timeJob Summary: We are seeking an experienced and strategic Manager – Market Access to lead market access activities, ensuring optimal pricing, reimbursement, and patient access for pharmaceutical products. The role requires strong cross-functional collaboration with Commercial, Medical Affairs, Regulatory, and Health Economics teams to develop and execute...
-
▷ 15h Left! Manager
4 weeks ago
Vadodara, India SUN PHARMA Full timeJob Description Job Description - Preparation of registration strategy for various health authorities like Brazil and other Latin American countries i.e. Peru, Ecuador, Colombia, Panama - Adequate understanding on Brazil guidance and filing of new product and post approval changes - Review of documents related to product registration and dossier submission...
-
Assistant Manager Regulatory affairs
5 days ago
Ahmedabad, India Biotech Healthcare Full timeJob Description Role Objective Key objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements. The role ensures timely preparation and updating of Technical Master Files, supports product registrations, manages post-market surveillance activities, and...
-
Vadodara, India SUN PHARMA Full timeJob Description Job Title Executive Regulatory Affairs Business Unit R&D1 Regulatory Affairs Job Grade G12A Location : Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As...
-
Relationship Manager
1 week ago
Chennai, Tamil Nadu, India Airtel Full time ₹ 9,00,000 - ₹ 12,00,000 per yearRelationship Manager - Chennai - B2B Accounts - DirectKey Deliverables • To Ensure 100% service level adherence to business processes • To increase Collection Efficiency : 0-60 days, 60-90 days • To enhance the Revenue enhancement -Churn Control and Upsell. • To manager Manage and up sell existing & new airtel products/services to corporate through...
-
Meerut, India Hayai Pharma Private Limited Full timeJob Description Company Description Hayai Pharma is the Exporter of finished formulation of medicines accross various geographies. Role Description This is a full-time on-site role for a Senior Manager Regulatory Affairs, based in Meerut, Delhi NCR. The Senior Manager Regulatory Affairs will be responsible for preparations of filings for product or site...
-
Medical Writer
3 days ago
Bengaluru, India Biocon Biologics Full timeJob Description Medical Affairs Writer JD 1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards. 2. Collaborating with the clinical team in developing and strategizing the Clinical...
-
Global Program Manager
3 weeks ago
Bengaluru, India Biocon Biologics Full timeJob Description At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global...
