Associate Director, Regulatory Affairs (Import/Export)

Job Description
The Associate Director of Regulatory Materials Compliance US subsidiary will be responsible to provide leadership and oversight ensuring compliance of US regulatory import and export requirements. This includes Commercial (Drug-NDA, Biologics-BLA, Combination Products and Devices) and Investigational (US IND) material imported/exported into/out of the United States.
Primary Responsibilities:
Supports specified activities surrounding compliance to the U.S. Food and Drug Administration regulation for Importation of Approved and Unapproved drug/biologics/combination products across all divisions as detailed below:
- Serves as primary interface between our Company and FDA Ports of Entry and Division of Import Operations as it relates to imports
- Responds/resolves to FDA import Notices of Actions, which prevent materials from entering the United States. These include but are not limited to detentions, holds and examinations
- Identify issues that cause Notices of Action to be issued and proactively recommend what could help prevent this in the future
- Pro-actively mitigates operational impediments minimizing supply chain interruption. This could equate to loss of revenue, stock outs or shortages, and clinical trial disruption
- Cross functionally interact closely with groups such as Global Trade Compliance, Supply Chain Management, Internal Legal Counsel, Internal Quality Groups, Manufacturing Facilities, and various Commercial and Clinical Supply teams
- Continue to strengthen relationships and trust with such groups as the FDA Division of Import Operations and Policy and FDA Office of Compliance
- Develops import strategies which include new product launches, supply chain changes and initiation of clinical trials for all drugs, biologics, combination devices, intermediates, etc.
- Serves as the regulatory contact to provide key regulatory data elements (information) to import material into the United States. The system that is used Automated Commercial Environment International Trade Data System (ACE/ITIDS)
- Author various FDA official correspondence/documentation which include Intended Use Statements, Import for Export, and other supporting documentation
- Attend and participate in industry seminars and trainings to ensure compliance with US Customs and FDA Regulations
- Working with Government Affairs and Regulatory Policy on proposed/new legislation impacting imports and/or other areas that the group is responsible for
Required Education:
- Advanced degree with 5 years of relevant experience or BA/BS degree with 7-10 years of relevant experience in the pharmaceutical/bio industry preferably in Regulatory Affairs, Clinical Research, US Import and Export, Supply Chain or Trade Compliance
Required Skills:
- Critical thinking
- Excellent organizational skills
- Exceptional collaboration and negotiation skills
- The ability to solve complex problems
- Excellent written and verbal communication skills
- Outstanding time management; the ability to balance a large project load
Preferred/Required Experience and Knowledge
Required:
- Ability to effectively interact with various levels of management
- Understanding of Pharmaceutical Supply Chain
- Knowledge of FDA regulations on INDs/NDAs/BLAs
- US Import/Export Regulatory Knowledge- Federal Food, Drug and Cosmetic Act (FD&C Act)
- - Code of Federal Regulations (CFR)
- - FDA Supplemental Guide for the Automated Commercial
- Environment/International
- Trade Data System (ACE/ITDS)
- Experience in directly interacting with FDA in CDER and/or CBER
- Experience in launching and distributing new products including the following import strategy:- PLAIR (Pre-launch Activities Import Request)- FTZ (Foreign Trade Zone)
- General knowledge of Customs and Border Protection Regulations - US Department of Agriculture, Department of Fish and Wildlife and Drug Enforcement Agency knowledge helpful
- General knowledge of Chemistry and Controls (CMC)
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe
Who we are ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
Invent. Impact. Inspire.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Residents of Colorado
Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role's pay range.
GRACSJOBS
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
Secondary Language(s) Job Description
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEOC GINA Supplement?
OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP\EEO\Supplement\Final\JRF\QA\508c.pdf)
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Flex Time, Work Week
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
No
Number of Openings:
1
Requisition ID: R119437