Regulatory Affairs Manager
SteriMax Inc.
Full time- 3+ years
- Not Disclosed
- Hyderabad, India
- Post Date: Mar 18, 2024
- End Date: May 18, 2024
- 3+ years
- Not Disclosed
- Hyderabad, India
- Post Date:Mar 18, 2024
- End Date: May 18, 2024
Skills:
- Regulatory Affairs
- Inspection
- Management
Job Description:
Responsibilities
- Manages and provides leadership to an efficient and effective regulatory affairs team. Assists in the career growth of Associates and Senior Associates.
- Plans and manages regulatory submissions and activities for products throughout the life-cycle of a product in compliance with Health Canada regulatory requirements and ICH guidelines. Reviews submissions, including deficiency letters, to ensure timeliness, accuracy, consistency, completeness, and compliance with regulatory standards.
- Ensures that technical data and regulatory summaries are presented clearly and succinctly to optimize the regulatory authority review and approval process.
- Provides support to junior staff in the creation of submission documents and coach as necessary to ensure continuing development of regulatory skills.
- Ensures regulatory maintenance of approved drug products.
- Helps regulatory staff overcome difficulties in the completion of projects by diplomatically managing relationships with business partners, regulatory agencies and internal staff. Provides strategic guidance and advice.
- Contributes to the creation of submission strategies throughout the product life cycle.
- Shows good judgment to determine when to escalate problems to the Director of Regulatory Affairs.
- Tracks critical attributes of projects to ensure accountability and efficiency.
- Creates or supports the generation of reports as required.
- Supports the Director in developing and implementing departmental goals to coincide with corporate goals.
- Contributes to the creation and implementation of standards and best practices within the department to improve efficiency and quality of processes.
- Reviews internal documentation (labeling, master batch records, specifications) and external documentation (clinical reports) for adherence to regulatory guidelines.
- Builds and maintains a healthy working relationship with business partners. Liaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters.
- Builds and maintains a good working relationship with regulatory agencies. Uses the relationship to understand expectations beyond that which is presented in guidelines and policy statements. Maintains current awareness of regulatory guidelines (Health Canada, ICH, FDA, etc.).
- Provides sound regulatory input and support to product development and technical transfer projects.
- Represent Regulatory Affairs on interdepartmental teams for projects with Operations, Development, QA, Marketing, and other functions as required. Provides cross-functional review/input from a regulatory, scientific and technical viewpoint. Maintains and applies knowledge of product data, marketing objectives, and quality procedures.
- May perform other regulatory affairs functions and activities as required to achieve departmental or operational priorities and prioritizes other responsibilities to meet additional work requirements.
Qualification & Experience
- University degree in Science, Pharmacy, Life Sciences with post-graduate certification in Regulatory Affairs program.
- No less than 8 years of relevant industry experience
- No less than 3 years of relevant Health Canada and sterile injectable experience
Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years of Experience"
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Salary
Not Disclosed
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Role
Manager
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Area of Practice
- Regulatory Affairs
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Experience
3+ years
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