1+ months

Director - Regulatory Affairs

Alfasigma USA
Bedminster, NJ 07921
  • Job Type
    Permanent
Job Duration
Job Start Date:


The Regulatory Affairs Director will be responsible for designing and implementing a viable regulatory strategy that provides a speedy and optimal access of new products to the market while ensuring that the regulatory status of Alfasigma USA (ALUSA) products is fully compliant and updated in accordance with applicable US regulations and Alfasigma Group internal policies. Masters the different regulatory environments as required and engages with government bodies, external consultants, and industry associations to discuss and protect ALUSA interests.

KEY FUNCTIONS:

Regulatory:

  • Design and implement the optimal regulatory strategies to speed and optimize new product launches
  • Advise in product development to ensure that regulatory requirements are considered
  • Identify and create opportunities for innovative product claims, product positioning and support development of the business strategy
  • Contribute with regulatory expertise to qualify Business Development and New product opportunities and provide regulatory review of projects at each stage gate.
  • Manage communication with health authorities and key stakeholders to drive regulatory and pricing strategy
  • Update and maintain the Regulatory dossiers to ensure that ALUSA products are fully compliant and up to date with existing legal requirements


Compliance:

  • Ensure full regulatory compliance of all labels and labeling for all products, including advertising, website, and sales collateral, with particular attention to protecting medical food designation and scientific claim substantiation
  • Comply with Pharmacovigilance legislation and requirements, ensuring the right systems for identifying, tracking and reporting AE's
  • Ensure that ALUSA has the required SOP's and internal procedures to be fully compliant with applicable legislation, guidelines and Group policies in the incumbent areas of responsibility
  • Identify, assess and clearly communicate to the business any regulatory risks with recommendations for options for risk elimination or mitigation.
  • Provide regulatory interpretation and guidance cross functionally to the business; specifically to product design and marketing for appropriate product claims and consumer advertising and communications, as well as to global teams about US-specific regulatory environment
  • Advise on product variances and compliance criteria


Manufacturing Support:

  • Support to the Manufacturing Quality Head to ensure that all manufacturing dossiers and related documentation are fully compliant with applicable laws and regulations.


Development:

  • Provide training, development, and coaching to managers and specialists with the aim of building succession planning and strengthening regulatory team contributions


REQUIREMENTS:

  • Bachelor's degree required; Life Sciences, Pharmacy or Chemistry preferred
  • PhD preferred
  • 5+ years Regulatory Affairs experience in the pharmaceutical industry required
  • High exposure to and involvement with industry groups, government authorities (FDA), and scientific societies

WHO WE ARE:

Alfasigma USA is the local affiliate of the Italian based pharmaceutical company, Alfasigma. The company was formed, in 2015, as a result of the merger between two historic Italian pharmaceutical companies, Alfa Wassermann and Sigma-Tau. Alfasigma is a leading Italian pharmaceutical company focused on prescription drugs, over-the counter (OTC) and nutraceutical products and has a presence in 90 countries.

Alfasigma USA's main goals are to improve the health and quality of life of patients by finding solutions to treat specific patient populations, expand our existing portfolio and bring new products into the US market. We strive to be a strong healthy company in a strong healthy world.

Alfasigma USA is headquartered in Covington, LA., has a manufacturing plant in Shreveport, LA., a mail order pharmacy call center in the Covington location and an established national salesforce. In addition, a commercial operations hub opened in 2018 in Bedminster, NJ.

Alfasigma USA, Inc. offers:

  • Competitive base salary
  • Annual bonus potential
  • Comprehensive benefits package (Medical, Dental, 401K and Paid Time Off are some examples)
  • Tuition reimbursement; financial support for continuing education programs



Alfasigma USA, Inc. and its subsidiary, Brand Direct Health, L.L.C. (collectively the "Company") is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee on the basis of race, religious creed, religious observance, color, age, sex, sexual orientation, gender, gender identity, gender expression, genetic information, national origin, ancestry, marital status, medical condition as defined by state law (cancer and genetic characteristics), disability, military service, military and veteran status, pregnancy, childbirth and related medical conditions, or any other classification protected by federal, state, and local laws and ordinances. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on the Company. Please email Human Resources at if you need assistance completing any forms or to otherwise participate in the application process.


Requirements

Regulatory, Quality Assurance, FDA, Labeling,

Salary Details

Base Salary + 20% Bonus Potential + Benefits

Categories

Posted: 2020-06-05 Expires: 2020-09-09

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Director - Regulatory Affairs

Alfasigma USA
Bedminster, NJ 07921

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