Manager, Regulatory Affairs
The Regulatory Affairs Manager (RAM) will work closely with the Regulatory and Clinical Affairs department to plan and coordinate all activities from pre-submission to approval of products in client development portfolio including 505(j) and 505(b)(2) applications. The Manager will work with product development teams to guide the development activities according to the regulatory requirements. He/she will be responsible for providing operational leadership, for communicating the regulatory requirements to the team, authoring certain portions, and overseeing editing and publishing of final submissions to meet appropriate requirements.
The Regulatory Affairs Manager will also assist with the nonclinical and clinical studies, including design, review of protocols, site monitoring, and finalization of reports for submission. He/she will be responsible for collecting, reviewing and preparing documents for submission in timely fashion. The Regulatory Affairs Manager will make sure that all product related activities occur according to state and federal guidelines. He/she will apply for all necessary approvals and marketing permits from the FDA as well as international regulatory offices, and track, obtain and renew any required permits and licenses. The Regulatory Affairs Manager will participate in the site quality activities review and approve necessary change controls to comply with regulatory compliance.
The Regulatory Affairs Manager will also help in setting up standard operating procedures pertaining to all aspects of regulatory activities including conduct and management of clinical studies, labeling and pharmacovigilance. He/she will develop and maintain excellence in knowledge of worldwide regulatory procedures and requirements.
- Actively contribute to the development and implementation of regulatory strategies, processes and timelines for US and global approval.
- Provide regulatory input to 505(b)2 product life-cycle understanding and planning from product selection stage through R&D and FDA submissions ensuring that overall regulatory strategy aligns with the target product profile (TPP).
- Manage interactions with other functions (e.g., Quality, Operation and Compliance) to ensure compliance with regulatory requirements for day-to-day operation and Quality Audits (Internal or Regulatory Authority).
- Monitor competitive regulatory and clinical practices, and actively review internal and external factors to mitigate potential problems.
- Support efficient and effective clinical trials including site selection, clinical trial management(study visits, training, monitoring etc.), data analysis, final study reports and publication while ensuring all clinical studies operate to the highest accuracy and completeness in compliance with the highest ethical and safety standards. Assist with Pharmacovigilance compliance and support for US reporting requirements. Provide global and US regulatory labeling expertise to teams
- Ensure that draft labeling complies with all applicable regulations and guidelines
- Work with cross-functional teams to ensure that desired label statements will be adequately supported by submission documents
- Interacts with key scientific, clinical research, and commercial personnel within and outside the company to ensure timely and accurate regulatory compliance.
- Responsible for all aspects of regulatory submissions, including IND, BLA, ANDA, NDA and major Supplements in electronic format per the eCTD requirements.
- May manage assigned personnel
- Occasional travel will be required
- Performs other functions as required or assigned
- Complies with all company policies and standards
- Demonstrated ability in analytical reasoning and critical thinking skills
- Strong capability to contribute in a team environment
- Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
- Excellent communication skills; both oral and written
- Strong interpersonal skills with the ability to influence others in a positive and effective manner
- Demonstrated ability to contribute to a continuous learning and process improvement environment
- Capacity to react quickly and decisively in unexpected situations
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
- Focused ability to influence operational excellence and performance metrics
- Risk adverse where needed with the ability to identify potential solutions to complex problems
- 8+ years relevant pharmaceutical industry and regulatory experience
- Bachelor’s degree in science or health related field. Advanced degree preferred.
- Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
- Knowledge of domestic and international laws, regulations, and guidance that affect Brand products
- Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
- Demonstrated experience with health authority submissions, i.e, authored, reviewed and managed an original/supplemental application (IND, NDA, ANDA, MAA, CTA, NDS, etc.
- Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for Brand products
- Ability to influence and partner with cross-functional teams in a pharmaceutical organization
- Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
- Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
8+ years relevant pharmaceutical industry and regulatory experience
Bachelor’s degree in science or health related field. Advanced degree preferred.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Job posted: 2020-09-22