Regulatory Manager
Syneos Health · Remote · remote · Posted 42d ago
Undisclosed10–15 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone s life.
- We are continuously building the company we all want to work for and our customers want to work with. WhyBecause we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone s life.
- We are continuously building the company we all want to work for and our customers want to work with. WhyBecause we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Job Description
JOB RESPONSIBILITIES
- Should have min 10+ yrs of experience in regulatory affairs .
- Should have functional lead experience of leading the team.
- Should have risk assessment capability and strategic thinking, decision making and leading project.
- Should have experience in handling internal and external stakeholder.
- should have M. pharm degree
- Should have experience of CMC module 3, authoring of CMC sections of Post Approval variations and life cycle management activities
- Should have in EU, GCC mkt experience.
- For non-complex and complex submissions, independently fulfill the following responsibilities:
- Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
- Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
- Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
- Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
- Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
- Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
- Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
- Ensure compliance with appropriate global regulatory requirements and the company s policies and processes.
- Prepare training materials and share best practices in the regulatory area, both internally and externally.
- Participate as regulatory support in internal or external project audits.
- Participate as regulatory support on internal cross-functional initiatives.
- Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
- Provide support in oversight to team members in the execution of their project responsibilities.
- Capable of identifying when to ensure line support required to provide additional guidance and direction.
- Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.
QUALIFICATION REQUIREMENTS
- Master's degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience.
- Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions.
- Excellent interpersonal / communication skills including excellent written and verbal communication skills.
- Excellent customer service skills, with the ability to work both as a team member and independently.
- Good quality management skills.
- Advanced skills in Microsoft Office Applications.
- Ability to interact with staff from multiple departments and offices to establish project standards.
- Good initiative, adaptability, and pro-activity.
- Strong analytical skills, good attention to detail.
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
- Fluent in speaking, writing, and reading English.
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Customer ServiceHTTPAgilemedical writingRisk AssessmentHealthcareAdministrationNDAPharmaLife Sciences
About Syneos Health
Syneos Health
Clinical Research
3.3k+
employees
1984
42 years old
Hyderabad / Secunderabad, Telangana
India
About
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success.
Industries
Clinical ResearchBiotech & Life sciencesAnalytics & KPO
Employee ratings
813 reviews
3.6/ 5
Culture
3.5
Career growth
3.0
Work-life
3.7
Employees rate it well for
Work Life Balance184Work Culture94Salary76Senior Management70Career Growth49
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