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12 days old

Associate Director of Regulatory Affairs

Kelly Services
Rockville, MD 20851
Kelly Scientific is working with an exciting Pharma company that is creating innovative manufacturing platforms to enable production of critical medicines at the point of care to secure the pharmaceuticals supply chain. They are seeking an **Associate Director of Regulatory Affairs** - an exciting opportunity to make a difference in the world while developing your career path.


Job Title: **Associate Director of Regulatory Affairs**

Location: **Rockville, MD**

Salary: **$180-200k**

**Position Responsibilities:**

Ensuring timely development of regulatory strategies.

Lead and support regulatory agency meetings including meeting preparation and briefing document creation; Ensure timely and sound responses to regulatory agency requests.

Lead the creation and submission of US FDA filing and potentially international dossiers.

Build, manage and lead the regulatory affairs team.

Assess and strategize post-approval changes and relevant submission. Strategically interpret and communicate regulatory requirements to development teams.

Proactively identify project issues, reports progress regarding objectives and plans and implement appropriate regulatory strategies to mitigate risks.

Provide guidance and support CMC development lifecycle including chemical synthesis, process characterization and optimization, control strategy, etc.

Lead internal review and approval process for CMC related submissions and regulatory questions.

Prepare regulatory impact assessments for change control management and deviation reports

Provide guidance and perform technical review of analytical test methods, specifications, and stability protocol/report/data.

Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content.

Lead the author CMC amendments, supplements, and annual reports.

Support internal audits and external inspection and/or audit from regulatory agencies and/or notified bodies, focusing on CMC.

Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product

Provide consultancy regarding drug development including timeline management.


**Qualifications:**

MS or higher in Chemistry, Biology, Chemical Engineering, or related field.

7+ years experience in authoring and/or review of CMC sections for DMF, NDA, BLA, IND, and/or IMPD, preferably of generic drugs.

Strong knowledge, deep understanding and demonstrated practice of 21 CFR part 210, 211, 11 and cGMP.

Ability to work with stakeholders from cross-functional team, including development team, GMP Operations and etc. internally and contract service suppliers.

Detail-oriented team player with strong written and oral communication skills.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-06-15 Expires: 2022-07-16

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Associate Director of Regulatory Affairs

Kelly Services
Rockville, MD 20851

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