Regulatory Affairs Manager
Location
Secunderabad | India
Job description
Position Overview
The Manager of regulatory and Strategic Development will be responsible for developing and implementing and regulatory strategies for client projects
The incumbent will be responsible for the strategy and preparation of regulatory and labeling-related projects for the US FDA, EU and ROW regulatory authorities.
The position will include client and regulatory authority liaison. The position will include the supervision and management of regulatory professionals and support personnel.
Job Duties And Responsibilities - Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets, Publishing electronic regulatory submissions (eCTD).
- Submission build activities, creating inter-document links, performing quality checks and validating compiled submissions, and finalizing submission by required dispatch date.
- Co-ordinate & engage with RA Ops team for timely submissions / Publishing tasks.
- Reviewing manufacturing documents like MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol and PDR.
- Create, monitor and maintain timelines for client strategic development, submission management and regulatory affairs programs.
- Develop and execute on global strategic plans (regulatory and/or quality systems) for the development of client medical device development programs, Act as subject matter expert in certain areas of EU MDR / IVDR
- Establish and direct cross-functional teams of internal and external personnel to deliver client projects.
- Support Regulatory Operations / Submission management Automation / IT efforts
- Provide training for in-house personnel and supervise the assigned Regulatory staff as needed.
- Participate in meetings with regulatory authorities
- Monitors activities of applicable regulatory agencies and industry organizations to identify any changes in regulations and communicate to appropriate personnel.
- Shows an understanding of the changing regulatory environment and the impact on business practices, policies and projects and demonstrates an ability to discuss relevant points in a diverse forum in more general terms.
Supervisory Responsibilities - Directly supervises employees assigned. Carries out supervisory responsibilities by the organization's policies and applicable laws.
- Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Manages applicable portions of established departmental budget, using good judgment to ensure that costs are appropriate and reasonable and that any foreseen overages are communicated for transparency.
Qualifications - Any Bachelor/Master in Any Life Science with a Minimum 7-12 years of experience within CRO / Biotech / Biopharma industry.
- Gap Analysis, Hands-on experience in publishing and Knowledge on CTD compilation
- The ability to deal effectively with sponsors and internal customers at all levels.
- Excellent communication and interpersonal skills, both written and spoken.
Role: Regulatory Affairs - Manager
Industry Type: Clinical Research / Contract Research
Department: Regulatory Affairs
Employment Type: Full Time, Permanent
Education UG: Any Graduate
PG: Any Postgraduate, MBA/PGDM in Any Specialization
Doctorate: Doctorate Not Required
Skills: regulatory affairs,publishing,electronic common technical document (ectd),regulatory submissions
Job tags
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