About the job
POSITION DESCRIPTION
Reporting to the Team Leader of Post-Approval Regulatory Affairs, the Regulatory Affairs Associate will prepare regulatory submissions for Health Canada and actively participate in the management of submissions under regulatory agency review in order to fulfill regulatory jurisdiction requirements. The Regulatory Affairs Associate is expected to interpret regulatory requirements, meet approval timelines for new product launches, and ensure that regulatory requirements are met in support of existing commercial products to Health Canada.
KEY RESPONSIBILITIES
Prepares generic drug product submissions for Health Canada (e.g. NCs, SANDSs, DINAs, etc.). Ensures that submissions are accurate and meet format and content requirements.
Reviews, evaluates, prepares, and files deficiency responses to Health Canada in a timely manner within given deadlines.
Evaluates change requests.
Reviews and contributes to implementation of post-approval changes of drug products.
Interprets scientific data and conclusions from CMC reports and summaries.
Attends, and may organize and facilitate, meetings and teleconferences with external partners and internal stakeholders to maintain progress of projects. Tracks and communicates critical attributes of projects to ensure accountability and efficiency.
Maintains a healthy working relationship with business partners. Liaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters from Regulatory Agencies.
Contributes to an efficient and effective regulatory affairs team, and uses knowledge and expertise towards a culture of continuous improvement.
Maintains current awareness of regulatory guidelines (Health Canada, ICH, FDA, etc.) and shares knowledge with the department.
TECHNICAL SKILLS:
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner
Understanding of Health Canada and ICH regulatory guidance documents and policies
Proficient computer skills, including MS Office applications and Adobe Acrobat; Experience with eCTD publishing tools is an asset
LEADERSHIP SKILLS:
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events
Capability to handle multiple priorities and balance work to achieve business goals
Demonstrated effective communication, and interpersonal skills on business commitments and project timelines
QUALIFICATIONS:
University Degree in Science or Life Sciences and post-graduate certification in Regulatory Affairs program
Prefer a minimum of 2 years of experience in drug submissions for Canada, preferably with parenteral dosage forms
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Dewas | Gwalior | Indore |Maharashtra :
Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata | Mukundapur |Alaska :
Anchorage | Barrow | Bethel | Juneau | Wrangell |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | Tempe | Tucson | Yuma |California :
Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |Colorado :
Denver |Connecticut :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta |Hawaii :
Honolulu |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |LA :
Monroe | New Orleans |Maryland :
Baltimore | Elkridge | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New York :
Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Syracuse |North Caroline :
Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |Ohio :
Columbus, |Oregon :
Bend | Corvallis | Eugene | Roseburg | Springfield |Pennsylvania :
Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Wyomissing |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |Tennessee :
Nashville |Texas :
Austin | Dallas | Houston | Richardson |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Goldendale | Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Wyoming :
Cokeville |Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Denmark :
Copenhagen |Hungary :
Budapest |Istanbul :
Turkey |Serbia :
Belgrade |Switzerland :
Basel | Zurich |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Hubei :
Wuhan |Republic of China :
Beijing |Tokiyo :
Osaka | Tokyo |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
London | Salt Lake City |Republic of Ireland :
Dublin | Limerick |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Remote, USA | Switzerland | Remote | Remote - Europe |Makkah :
Riyadh | Khulais | Rabigh | Jeddah | Najran |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |