Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, diversified 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: Associate Director Global Strategy Regulatory Affairs & Advocacy
Job Description:
The Associate Director Global Strategic Regulatory Affairs and Advocacy provides strategic regulatory leadership and direction across the region (Europe/Middle East/Africa (EMEA), Asia Pacific or Latin America/Canada) in collaboration with the nutrition, pharma, medical device and diagnostic products businesses as well as Abbott Corporate groups such as Abbott Quality and Regulatory (AQR), Government Affairs and Legal. This role includes establishing and strengthening Abbott’s position as an accepted working partner across the industry with key industry stakeholders and regulatory authorities, strategically influencing, through coordination across Abbott and with trade associations, emerging regulatory issues impacting Abbott and communicating to Abbott management to ensure effective knowledge of, and planning to address key regulatory challenges.,
Abbott Division – Provide regulatory support and advocacy across int’l geographies. Provide strategic influence, both individually and through coordination across affiliates, with trade associations and key regulatory stakeholders and authorities. Communicate effectively with Division management and contribute to impact analysis of emerging regulatory issues to anticipate and prepare for compliance within the division.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function:
- Provide leadership and support for division regulatory and quality activities such as pre-market/post market product support including regulatory strategy, regulatory submissions and registrations,
- Provide leadership in industry led working groups which can influence developing regional regulatory issues and business trade barriers. Influence emerging policies, regulations, standards, and industry positions in the Region through effective participation and leadership in such relevant organizations,
- Provide coordination across Abbott businesses and other Abbott groups to ensure Abbott’s position is consistently advocated externally,
- Develop/maintain professional relationships with key global regulatory agencies and industry groups to ensure access, influence, and goodwill/understanding for the benefit of Abbott. Monitor and report on trends to provide early alerts so that strategic positions can be developed and employed or refocused,
- Analyze trends and reports to provide recommendations for positions, actions, and deployment,
- Provide expertise and recommendation in interpretation of complex regulatory issues,
- Serve as a key contributing leader of the Abbott RA Council to present regional emerging issues for the Council’s deliberations and action,
- Develop RA professionals in the skills and knowledge regarding strategy development and management of key regulatory issues.
GO TO NEXT PAGE FOR MORE INFO...
Subscribe to Pharmatutor Job Alerts by Email
ACCOUNTABILITY / SCOPE:
The RA strategy and advocacy role is responsible for ensuring that the regulatory policies and strategies of the nutrition, pharma, medical device and diagnostic product businesses address the dynamic global markets and that new emerging issues are handled such that there is minimum or no negative impact to the business.
Influence/Leadership:
This position is responsible for taking leadership roles in industry-wide working groups in the Region and helping to define the charter for advocacy in relation to influencing global national regulatory policies, regulations, guidance, and laws. This position supports all Abbott divisions in the Region, working to develop Abbott strategy and policy and communicating these policies such that there are consistent approaches utilized across the
businesses. Significant interaction with a variety of management levels including executive management on significant matters, often requiring the coordination of activity across organizational units.
Planning/Organization:
Anticipates regulatory emerging issues and develops solutions to them. Identifies the need for new regulatory policies/processes. Develops solutions and corporate positions to address emerging regulatory issues with other members of management and stakeholders based upon proposed regulatory requirements and risk- benefit
Decision Making/Impact:
Recognized as key resource in regulatory affairs. Develop, communicates, builds consensus for goals that are in alignment with the corporation. Exercises judgment independently. Knows when issues need to be elevated.
Candidate Profile:
The position requires at least 8 years of experience in a regulated industry such as medical products, pharmaceuticals, and nutritionals (including management experience); 5-7 years of direct regulatory experience. Note: Higher education may compensate for years of experience.
Required skills include ability to work across organizational and management levels, work across boundaries and diverse cultures; excellent communication skills (oral and written), strategic thinking and planning skills, leadership presence; desire to perpetuate an open trustworthy, credible environment that gains the respect of peers and colleagues inside and outside the organization. It is necessary to possess effective interpersonal skills due to the extensive interaction with Government agencies and Abbott management.
This position requires a sound business judgment, interpersonal and communication skills to deal with diverse and complex Abbott international business units and external regulatory agencies. This position will need to work with multiple and sometimes conflicting priorities. Timeliness is essential for the activities that are involved in keeping business needs met. The person must have the ability to analyze complex issues, develop pertinent strategic proposals and policies, identify business opportunities, and make sound relevant recommendations as to possible alternatives to achieve divisional objectives. The ability to make decisions and recommendations that are based upon sound regulatory knowledge and judgment, as well as the proper balance between cost optimization versus compliance is essential.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day). Frequent international travel required
B.S or B.A. in a technical area (such as biology, chemistry, engineering, microbiology, immunology, medical technology, pharmacy); M.S. in a technical area or M.B.A. is preferred; a Ph.D. in a technical area or law is helpful; certification is a plus (suc
Additional Information:
Location: Delhi
Education: B.S., M.S., MBA, Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, DRA
Keyword or Job ID: 94087BR
End Date: 18th August, 2011
To Apply/Send your resume, Click Here
See All Abbott Jobs B.Sc Alerts B.Pharm Alerts Mumbai Alerts
See All Other Jobs in our Database
.png)
