Regulatory Affairs Director jobs in Pennsylvania
Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Director jobs
Director, CMC Regulatory Affairs
- GSK
-
Collegeville, PA
FULL_TIME
-
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware, UK - London - Brentford
Posted Date: May 17 2024
Job Purpose:
Leads CMC regulatory activities in the global lifecycle management of GSK biopharmaceutical products. Management oversight for a team ensuring compliance with GSK policies and procedures, staff development and training to deliver roles.
Key Responsibilities:- Represents Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing and overseeing strategic direction and guidance to Supply Chain, Quality Assurance, 3rd Party Contract Management, Commercial and wider GRA on both global project and key strategic business initiatives.
- Identifies key risks to the business associated with submission strategy and information packages and provides and communicates to senior management well defined risk mitigation strategies.
- Likely to have direct line management responsibility. Coaches and mentors staff across CMC RA on lifecycle management in CMC.
- Responsible for managing budget and resource for their teams. Responsible for team compliance with GSK policies and procedures, staff development and training to deliver roles.
- Has effective organisational (internal and external) networks. Leads influences and motivates staff within and across departments.
- Commercially astute and organisationally aware and able to deal with sensitive and confidential issues. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
- Delivers CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (LICs/PIRCs).
- Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of the company. Leads the company position to influence the internal/external CMC Regulatory environment through specialist areas of intelligence.
- Has accountability for submission content. Understands, interprets, and advises on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of pharmaceutical products, to expedite submission, review, and approval of global CMC applications in alignment with regional requirements.
- Directs resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC regulatory aspects across teams to support license maintenance and change control requests including transfer of supply within the company or with a 3rd party are delivered to agreed timelines.
- Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work.
- Operates with independence. Directs and communicates complex regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:- BSc in Life Sciences or related scientific discipline with 5 years of Post Approval CMC Regulatory experience for biopharmaceutical products
- Experience in leading major post-approval filing activities for biopharmaceutical products (e.g. significant manufacturing change and key regulatory interactions in lifecycle management)
- Experience in biopharm drug development and manufacturing and supply processes.
- Experience working with complex worldwide CMC regulatory requirements.
- Project management skills.
- Effective influencing and negotiating experience with regulatory agencies, industry bodies, and personnel within the company in a variety of settings.
- Experience handling complex global CMC issues through continuous change and improvement.
If you have the following characteristics, it would be a plus:- PhD in Life Sciences or related scientific discipline.
- Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines product support.
- Demonstrated ability to influence the global internal/external regulatory environment in the biopharm space.
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
- Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
- Identified as CMC Regulatory expert in a specific subject area.
- Proven experience in supervising and training staff within and across the organisation.
- Able to demonstrate the following key high-performance behaviours: customer driven, flexible thinking, and continuous improvement.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or 1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
- 5 Days Ago
Director Regulatory Affairs, Vaccines
- GSK
-
Collegeville, PA
FULL_TIME
- Site Name: USA - Maryland - Rockville, USA - Pennsylvania - Upper ProvidencePosted Date: Apr 30 2024Are you looking for a highly visible role where you can ensure the development and execution of appr...
- 5 Days Ago
Director, Government & Regulatory Affairs
- Comcast Corporation
-
Philadelphia, PA
FULL_TIME
- Comcast brings together the best in media and technology. We drive innovation to create the world's best entertainment and online experiences. As a Fortune 50 leader, we set the pace in a variety of i...
- 18 Days Ago
Director, Regulatory Affairs
- Jubilant Pharma Holdings Inc.
-
Yardley, PA
FULL_TIME
- Director of Regulatory Affairs Join Jubilant Radiopharma as our Director of Regulatory Affairs and be at the forefront of revolutionizing healthcare through innovative radiopharmaceuticals. About Us: ...
- 2 Months Ago
Director of Regulatory Affairs
- Extremity Care
-
Conshohocken, PA
FULL_TIME
- Purpose: The Director of Regulatory Affairs is responsible for overseeing all regulatory matters, to include the regulatory framework, submissions, and functions to ensure that the quality management ...
- 3 Days Ago
Director, Regulatory Affairs, Specialty
- GSK
-
Collegeville, PA
FULL_TIME
- Site Name: USA - Pennsylvania - Upper ProvidencePosted Date: Mar 14 2024Are you looking for a highly visible regulatory leadership role where you can build advocacy and accelerate regulatory complianc...
- 5 Days Ago
Regulatory Affairs Director jobs at Popular Companies
Head of Regulatory Affairs
- Exegenesis Bio Inc
-
Ambler, PA
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Head of Regulatory Affairs
- EPM Scientific
-
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Director of Regulatory Affairs
- Verano
-
- Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
- 6/10/2024 12:00:00 AM
Head of Regulatory Affairs
- Hiring Now!
-
West Hills, CA
- HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
- 6/8/2024 12:00:00 AM
Director of Regulatory Affairs
- Catalyst Life Sciences
-
- Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
- 6/8/2024 12:00:00 AM
Head of Regulatory Affairs
- Kaye/Bassman International
-
San Diego, CA
- Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
- 6/7/2024 12:00:00 AM
Sr. Director of Regulatory Affairs - Oncology
- Mantell Associates
-
Boston, MA
- Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
- 6/7/2024 12:00:00 AM
Director of Regulatory Affairs
- Verano
-
Chicago, IL
- Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
- 6/7/2024 12:00:00 AM
About Pennsylvania
Pennsylvania (/ˌpɛnsɪlˈveɪniə/ (listen) PEN-sil-VAY-nee-ə), officially the Commonwealth of Pennsylvania, is a state located in the northeastern and Mid-Atlantic regions of the United States. The Appalachian Mountains run through its middle. The Commonwealth is bordered by Delaware to the southeast, Maryland to the south, West Virginia to the southwest, Ohio to the west, Lake Erie and the Canadian province of Ontario to the northwest, New York to the north, and New Jersey to the east.
Pennsylvania is the 33rd-largest state by area, and the 6th-most populous state according to the most recent of...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$169,557 to $241,492
Most Popular Cities in Pennsylvania for Regulatory Affairs Director Jobs
What does a Regulatory Affairs Director do?
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At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
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The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
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The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
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