Senior Manager, Global Regulatory Affairs
Millipore Corporation

Job Info

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EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

PURPOSE OF THE ROLE

• Assist in preparation of global regulatory strategies, particularly US, for development products
• Manage the submission and approval of applications for clinical trials and marketing applications, full submissions, amendments and supplements, particularly for US

KEY TASKS & RESPONSIBILITIES

• Represent GRA in Global Project Teams, in particular as US expert
• Lead GRA sub-team as applicable
• Manage the US regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation
• Manage the US regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (under supervision of a TA Head or Global Regulatory Lead)
• Prepare regulatory strategies for projects (may be under supervision)
• Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including IND documents and NDA/BLA documents

CANDIDATE'S PROFILE

EDUCATION/LANGUAGES

• Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
• Excellent spoken and written English, other languages appreciated

PROFESSIONAL SKILLS & EXPERIENCE

• Minimum of 7 years' industry experience of which at least 5 years' regulatory experience
• Experience in preparation and submission of IND/NDA through to authorization
• Experience with regulatory agency interactions and preparation of documentation to support interactions (meeting requests, briefing documents)
• Experience in CTA requirements outside of US
• Knowledge of international regulatory affairs
• Experience in preparation of Regulatory strategies under supervision
• Experience with maintenance of regulatory approvals in US
• eCTDs experience highly desired

PERSONAL SKILLS & COMPETENCIES

• Excellent written and spoken communication skills
• Good interpersonal skills
• Attention to detail
• Ability to work in teams
• Awareness of of external Regulatory Affairs events
• Good organizational and planning skills

ADA REQUIREMENTS

• Normal and routine office duties
• Position requires both domestic and international travel
• (non-exempts only: overtime may be required)
• Equal Employment Opportunity

The Company is an Equal Employment Opportunity employer.

No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.

This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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