Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post : Manager - Regulatory Affairs
Objectives
The responsibility of this position is to drive country regulatory and clinical strategies in alignment with company business goals ensuring timely registration of all new products for market growth and renewal of expiring product licenses for business continuity.
• Provides strategic clinical direction and consultation to all aspects of product commercialization, including product performance, customer communications, and scientific marketing.
• Provides RA &QA support in the resolution of product issues and promotion of ADD products.
• Represents ADD in meetings with key customers, government agencies, and scientific/professional organizations.
• Responsible for implementing and maintaining the effectiveness of the ADD quality system
Major Responsibilities:
• Stays current with literature in field; provides technical assessment and utility of key publications to sales and marketing staff.
• Assists marketing & sales in handling and overcoming product objections.
• Defines objectives and expectations for product evaluations and works with investigators to develop protocol. Assists the development of publication or in-house report and ensures final publication or distribution/presentation.
• Drive regulatory & clinical strategies in alignment with company business goals ensuring timely registration of all new products for market growth and renewal of expiring product licenses for business continuity.
• Ensures the organization complies with all relevant policies and procedures to ensure the Quality objectives of the business are met. Comply with all relevant company Occupational Health, Safety and Environmental policies, procedures and work practices with the intent of preventing or minimizing accidental exposures to self, colleagues and/or the environment.
• Develop and execute regulatory plans for new product registrations and renewal of all expiring licenses.
• Evaluate proposed changes to products and manufacturing processes for regulatory filing needs.
• Monitor regulatory changes and assess their impact and advise strategies to mitigate negative influence and communicate all these changes to RA and country management teams.
• Provide postmarket support to country management team when Quality group is absent eg. approving local country labeling prior to release and reporting of adverse events/recalls to regulatory agency.
• Review and approve Advertising and Promotional materials for all businesses to ensure regulatory compliance.
• Build long-term and win-win relationship/partnership with all external customers including regulatory agencies and industry groups
• Participate and actively lead in industry lobbying efforts to influence regulatory development in country to ensure minimal adverse impact on businesses.
Candidate Profile
• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering or medical fields is preferred.
• 4 years in a regulated industry. Regulatory area is preferred but may consider quality assurance and scientific affairs.
KEY REQUIREMENTS
Competencies
• Innovative and results driven
• Strong written and oral communication skills
• A high degree of social confidence and interpersonal skills.
• Excellent time management skills; ability to set priorities
• Ability to determine short and long range business needs
• Must possess strong problem solving techniques
• Must be willing to travel 25%-40%
• Must have demonstrated leadership skills
Additional Information
Qualification : B.Pharm, B.Sc
Location : Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
JOB ID : 30893624
End Date : 30th July, 2018
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