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Description
MCC Regulatory Affairs Franchise Lead - Digestive Health / Women's Health-REG000849
Description
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
This position will work collaboratively with Regional and Local Country Regulatory professionals and franchise research and development (R&D) and business colleagues to develop global regulatory strategies for new projects, to support the MCC Digestive Health and Women's Health Franchises.
Key activities include but are not limited to:
* Provide guidance and advice to R&D development teams, business partners, and to senior management on the regulatory requirements and milestones required for project success.
* Work closely with local country regulatory staff and MCC regulatory staff to ensure the production of dossiers that meet registration requirements in international markets
* Work cooperatively with Merck Research Laboratories (MRL) regional regulatory staff and Local country regulatory staff to ensure that MCC regulatory initiatives are executed as planned
* Monitor activities of trade group organizations and health authorities and advise MCC of new requirements and policies that affect MCC Digestive Health and Women's Health products
* Evaluate new business development and licensing opportunities
Qualifications
Education Requirement:
* Bachelors degree (preferably in a scientific discipline)
Required:
* Minimum of 10 years work experience
* Direct consumer or pharmaceutical regulatory experience (preferably including OTC and international experience).
* Demonstrated ability to influence organizational decision-making, experience in risk assessment and risk management together with sound business judgment.
* Must possess excellent strategic, collaboration, communication, organization and presentation skills.
Preferred:
* International Regulatory experience
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
merck.com/careers to create a profile and your resume for requisition # REG000849.
Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully:
Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Primary Location: US-NJ-Summit
Employee Status: Regular
Travel
: Yes, 25% of the time
Number of Openings: 1
Details:
Job Id:
34158895
Posted / Updated:
3/9/2012 3:54:00 AM
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