Kelly Services Regulatory Affairs Manager in New York, New York

Regulatory Affairs Manager in New York, New York (12 month contract)

Kelly Services is currently seeking a Regulatory Affairs Manager for one of our top clients

in NY, NY.

As a Regulatory Affairs Manager placed with Kelly Services, you will create and deliver strategic regulatory guidance for assigned projects/products. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines.

Additional Job Responsibilities:

• Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies; For assigned products, contribute to and provide review/approval for safety aggregate reports as required locally.

• Direct liaison with Health Authorities to facilitate the prompt review and approval of applications, supplements, and commitment closures.

• Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products.

• Lead and/or direct creation or revision of labeling per our client’s medical position or as instructed by Health Authority.

• Develop and implement regulatory strategies to support/maintain registrations. Maintain product licenses across all product platforms.

• Understand regulatory environment and communicate priorities to global/regional stakeholders

• Deliver project regulatory strategy, risk assessment, and PRS for assigned projects/products

• Ensures business compliance and implementation of and adherence to Regulatory standards.

• Lead and/or direct team discussion regarding project status in senior management forums.

• Prepare IRD and CTD submissions for NCE and line extensions including liaison with contributing groups and review of components. Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, minimize resource demands while maximizing overall project delivery time and probability of success.

• Ensure that product maintenance activities (product renewals, AQRT's, regulatory queries, etc.) are managed and responded to in line with product role, consistent with departmental procedures an including liaison with other functional groups to ensure that response targets are met.

• Liaise with internal and external technical experts responsible for preparation of expert documentation for inclusion in IRD and CTD submissions and apply regulatory expertise to enable preparation of high quality documentation.

• Advise on the development of regulatory documentation that meets relevant regulatory requirements and ensure that the documentation meets relevant regulatory requirements and that compliance with departmental procedures is assured.

• Co-ordinate with regional and country strategists the receipt, distribution and response to regulatory queries, in line with product role, consistent with departmental procedures and including liaison with RRT members to ensure that response targets are met.

• May lead preparation for, and attend where appropriate, meetings with regulatory authorities, including preparation of background materials, logistical organization and assisting in preparation of meeting minutes.

• Ensure that comprehensive records of communications and regulatory status are maintained.

Job Requirements:

Extensive experience in regulatory affairs required ; post marketing experience preferred, but not required

• Proven examples of delivery across a product’s lifecycle with demonstrable contribution in Regulatory Affairs.

• Regulatory experience including knowledge of NDA/IND, 505(b) (2) submission processes.

• Experience managing multiple products simultaneously and different stages of the product lifecycle.

• Experience in successfully communicating with major Health Authorities, including leading and participating in such interactions.

• Proven ability to consistently deliver to time, cost and quality standards.

• Strong written and verbal communication skills

Education:

• B.S. Scientific Degree required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.

Why Kelly?

With Kelly®, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 99 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.

As a Kelly Services employee, you will have access to numerous perks, including:

  • Exposure to a variety of career opportunities as a result of our expansive network of client companies

  • Career guides, information and tools to help you successfully position yourself throughout every stage of your career

  • Access to more than 3,000 online training courses through our Kelly Learning Center

  • Weekly pay and service bonus plans

  • Group- rate insurance options available immediately upon hire*

    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—connect with us today.

*Available for purchase and administered by a designated third-party vendor

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is committed to employing a diverse workforce.

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ 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—connect with us today.

AboutKelly Services ®

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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm