Kelly Services, Inc.
Seeking an Associate Director, Global Regulatory Affairs CMC for a 12 month assignment in Lexington, MA\r
\u2022 The CMC Regulatory Affairs Network Strategy Implementation Team Lead will provide leadership and be the Regulatory CMC point of contact for major projects in the Network Strategy Implementation workstream, including but not limited to, site-to-site technical transfers, QC transfers, changes to external network, and internalization. This will include formulating and implementing CMC regulatory strategies, lead CMC regulatory activities for assigned projects in line with US or ICH requirements, using contemporary submission standards, and owning all aspects of Modules 2.3/3.\u00a0\r
\u2022 Primary role includes:\u00a0\r
o Serve as the team lead for Network Strategy Implementation leads\u00a0\r
o Serve as a liaison between the network project teams and the GRA CMC Product Lead\u00a0\r
o Provide CMC RA leadership within RA and on cross-functional CMC teams\u00a0\r
o Maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations\u00a0\r
Describe the essential daily job functions and include % of time spent on each.\u00a0\r
\u2022 Provide CMC regulatory strategy for proposed changes or other related activities for commercial programs. (60%)\u00a0\r
\u2022 Facilitate timely regulatory approvals by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products (15%)\u00a0\r
\u2022 Lead other functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements. (15%)\u00a0\r
\u2022 Evaluate manufacturing change controls, assess regulatory impact, and support their implementation. (10%)\u00a0\r
Education and Experience Requirements\u00a0\r
\u2022 B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field\u00a0\r
\u2022 7 - 10 years of drug development experience including and/or significant strategic experience in CMC regulatory affairs with a strong biologics background.\u00a0\r
\u2022 Demonstrated leadership in regulatory strategy and experience in regulatory interactions\u00a0\r
Key Skills, Abilities, and Competencies\u00a0\r
\u2022 Ability to manage complex projects, timelines and teams in a matrix team environment.\u00a0\r
\u2022 Strong analytical and problem solving skills.\u00a0\r
\u2022 Ability to lead a team of multi-facility and multi-function employees to a successful outcome.\u00a0\r
\u2022 Strong communication and leadership skills.\u00a0\r
\u2022 Strong interpersonal, communication, influencing, and negotiation skills\u00a0\r
\u2022 Strong computer skills, excellent writing, organization, and presentation skills.\u00a0\r
\u2022 Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:\u00a0\r
\u2022 Be Positive\u00a0\r
\u2022 Be Accountable\u00a0\r
\u2022 Be Results-oriented\u00a0\r
\u2022 Be An Excellent Manager of Self and Others\r
For immediate consideration please call 732-246-0215 or email to firstname.lastname@example.org\r
With Kelly, you\u2019ll have access to some of the world\u2019s highest-regarded scientific organizations\u2014providing you with opportunities to work on today\u2019s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you\u2019ll be proud to help advance. We work with 95 of the Fortune 100\u2122 companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career\u2014connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.]]
Kelly Services, Inc.
Website : http://www.kellyservices.com
William Russell Kelly founded the company in Detroit on October 7, 1946, operating as the Russell Kelly Office Service. He is widely credited with pioneering the modern temporary help industry. The company was renamed Kelly Girl Service in 1957, and it became Kelly Services® in 1966 to reflect the growing services of the company. Established in the International Marketplace In 1968, Kelly Services opened its first international office in Toronto, Ontario, Canada. The company’s first European office opened in 1972 in Paris, France. Today, we offer a full suite of outsourcing, consulting, and staffing solutions—delivered globally from over a 70-year heritage of dynamic talent innovations. Total Sales Revenue in 2016 was $5.3 billion. Fortune U.S. Rank Kelly Services is currently ranked 490 in the Fortune 500 list of America’s largest companies.