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Job Details

Senior Regulatory Affairs Specialist

Company: JCW Life Sciences
Location: Watford
Reference: BBBH37932
Closing Date: 13 Dec 18
Type: Permanent
Salary (£): 30,000 - 40,000
Benefits:

Job Summary:

Main purpose of role Develop and applies intermediate knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Key tasks * Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies * Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g. ...

Requirements:

Main purpose of role Develop and applies intermediate knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.



Key tasks

* Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
* Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
* Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
* Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
* Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
* Evaluates proposed products for regulatory classification and jurisdiction
* Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
* Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
* Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
* Negotiates with regulatory authorities throughout the product lifecycle
* Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
* Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
* Assists other departments in the development of SOPs to ensure regulatory compliance
* Provides regulatory input and technical guidance on global regulatory requirements to product development teams
* Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
* Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
* Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
* Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships



Qualifications, skills and desirable experience

* BS in Engineering, Science, or related degree; or MS in Regulatory Science
* Typically a minimum of 3 years experience
* MS or RAC(s) preferred
* Project management, writing, coordination, and execution of regulatory items.
* Perform technical and scientific regulatory activities.
* Usually works with minimum supervision, conferring with superior on unusual matters.
* Assignments are broad in nature, requiring originality and ingenuity.
* Has some latitude for unreviewed action or decision.
* Seeks out diverse ideas, opinion, and insights and applies them in the workplace
* Connects and relates well with people who think and act differently than oneself
* Embraces scrutiny and accepts feedback as opportunity to learn and improve
* Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
* Navigates the dynamics, alliances, and competing requirements of the organization or business
* Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities

Apply for this job: Senior Regulatory Affairs Specialist

Contact Information:

Address:  Head Office
27-32 Old Jewry
London
EC2R 8DQ
England
Tel:  +44 (0) 203 589 9300
Fax:  +44 (0) 203 006 8808
Website:  Visit Our Web Site

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